Summary of MedSun Reports Describing Adverse Events With Long Term Intravascular Catheters and Related Article
MedSun: Newsletter #30, November 2008

By Elizabeth Eydelman, Patient Safety Staff, 2008

Over the past year and a half, MedSun has received 59 adverse event reports involving long term intravascular catheters associated with 11 manufacturers: Bard Access Systems (32), Becton Dickinson (7), BD Infusion Therapy Systems, Inc. (6), Boston Scientific Corporation (4), Arrow International, Inc. (2), Cook Medical (2), Cardinal Health Medical Products and Services (2), Advanced Medical, Inc. (1), HDC Corporation (1), Vygon Corporation (1), and Medcomp (1). The reports were submitted by 31 hospitals between January 1st 2007 and June 6th 2008. The most frequently reported device problems are:
• Device Breakage (22)
• Defective Device (wire difficulties, cracks, kinks, or leakage, dull scissors from kit) (21)
• Thrombus Development (11)
• Removal/Insertion Difficulties (9)
• Device Migration (4)


There are no MedSun reports that list death or other as the type of adverse event. There are 41 reports that list malfunction as the type of adverse event, 14 do not list event type, and 4 list event type as injury. The most frequently reported patient problems are:
• Need For Additional Treatment or Surgical Procedure (28)
• Need For Removal of Foreign Body (9)
• Need For Reinsertion (9)
• Required Hospitalization (4)

Of the reports that list patient age, 15 reports have a patient age less than 21 years and 37 reports have a patient age listed as greater than 21 years. Of the reports that provide patient gender, a total of 32 reports involve female patients and a total of 25 reports involve male patients.

These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices. The reported events are consistent with umbilical artery catheter problems reported in the literature. Many of these reports involve long term intravascular catheters that are peripherally-inserted central catheters (PICCs), accessing the central venous system via a percutaneous access site, usually in the upper arm. PICC placement combines the benefits that a central line offers for complex medication and fluid administration along with the advantages of peripheral insertion.

The February 2006 MedSun Newsletter Safety Tip, Preventing PICC Fractures, by Roberta Sullivan, RN, MPH stresses the need for health care practitioner awareness of PICC care guidelines to maintain catheter integrity will promote patient safety:

• Follow the manufacturer’s device-specific instructions for catheter placement and insertion site maintenance. Certain chemicals, solutions, or antibiotic ointments should be avoided near catheters made of materials susceptible to damage.

• Position in-line clamps near the center of the distal connector hubs. If the clamps are placed too close to the connector ends, excessive or repeated clamping may lead to tubing fatigue and stress fractures. However, failure to use the clamps may increase the risk of air embolism or blood loss.

• Secure the catheter to prevent occlusion, stress or kinking. Observe and monitor the length of the catheter from the placement site. Catheter migration from the intended placement in the superior vena cava can lead to serious complications such as perforation, erosion, and cardiac tamponade. Pediatric patients with PICCs pose special challenges for securing the catheter. Tubular elastic netting applied over the child’s arm may help prevent dislodgement and the need to repeat line placements in this high risk population.

• Always use at least a 10 cc syringe for flushes and medication administration. Flush the catheter with a brisk push/pause technique. To prevent damage to blood vessels or catheters, infusion pressure should not exceed 25 psi (pressure per square inch). The same force applied to a 3 cc syringe can result in a psi up to 55, compared to only 15 psi if using a 10 cc syringe. When using small gauge (< 4Fr) catheters in pediatric patients, a 10 cc syringe should still be used for medication and flushes, with the appropriate volume.

• Do not flush against resistance. Partial or complete catheter occlusions may be caused by thrombosis, drug precipitates or mechanical factors. Prevention of occlusion includes the use of heparin, positive pressure, and adequate flushing techniques between medications, blood draws, and TPN (total parenteral nutrition). Follow your institution’s protocol for appropriate interventions.

[Note: The reports have been edited for clarity]




MedSun Intravascular Catheter Adverse Event Reports received between January 1st 2007 and June 6th 2008
Device Device Identifiers Event Description
Bard Access Systems/Intravascular Catheter Lot: REQHO327 RN DRAWING BLOOD FROM THE WHITE PORT OF THE PICC WAS UNABLE TO DRAW. REMOVED SYRINGE AND NOTED WIRE IN HUB. TWO PIECES OF WIRE WERE PULLED OUT OF THE WHITE PORT HUB; ONE 1-1/4 INCH AND ONE 1/4 INCH.
Bard Access Systems/Intravascular Catheter Lot: REQHO327 PICC GUIDEWIRE WAS STRETCHED AT HUB - ALL WIRE WAS RETRIEVED.
Bard Access Systems/Intravascular Catheter Lot: REQHO239 WHILE ATTEMPTING TO RETHREAD THE PICC LINE OVER THE EXISTING LINE, THE PICC BROKE AT APPROXIMATELY 39 CM. RETRIEVAL OF THE PICC FRAGMENT WAS SUCCESSFUL.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Device Identifiers Unknown/Not available PT WAS TRANSFERRED HERE FROM ANOTHER FACILITY FOR RETRIEVAL OF PICC LINE WHICH DISLOCATED TO HER RIGHT VENTRICLE. PT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LAB. CARDIOLOGIST REMOVED 5CM FRAGMENT FROM RIGHT VENTRICLE WITH NO COMPLICATIONS. THE REST OF THE CATHETER WAS REMOVED WITH NO COMPLICATIONS. CHILD WAS TAKEN TO NICU. CHILD WAS TRANSFERRED BACK TO ORIGINATING FACILITY AFTER CHILD WAS STABLE. CATHETER WAS DISCARDED IN ERROR.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 6164550 DURING REVIEW OF CHEST X-RAY PERFORMED THE PREVIOUS EVENING, IT WAS NOTED THAT THE DISTAL SECTION OF A MIDLINE/PICC CATHETER LINE HAD BROKEN. A SECOND CHEST X-RAY CONFIRMED THE PICC LINE HAD BROKEN WITH A PORTION OF THE LINE LODGED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. INFANT TRANSPORTED TO ANOTHER FACILITY TO HAVE BROKEN PIECE REMOVED. PROCEDURE WAS SUCCESSFUL AND INFANT TRANSPORTED BACK TO NICU TO CONTINUE TREATMENT.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 6192590 RN ASSESSING BABY AND FOUND PICC LINE BROKEN IN TWO PIECES. ONE PART WAS ATTACHED TO THE PATIENT'S ARM AND THE END PIECE WAS LYING ON THE BEDDING. SOME WETNESS NOTED ON THE SHEETS BY THE BABY'S ARM. PATIENT'S ASSESSMENT UNCHANGED.TEMPERATURE AND VITAL SIGNS STABLE. ACCUCHECK 47. NEONATAL MD NOTIFIED. PICC LINE REMOVED AND SAVED. DEVICE IS AVAILABLE IN RISK MANAGEMENT OFFICE FOR INSPECTION. PERIPHERAL IV LINE STARTED. NO ADVERSE OUTCOME TO THE PATIENT.
Bard Access Systems/Intravascular Catheter Lot: REPL0183 PICC NURSE INSERTED THE LINE WITHOUT DIFFICULTY. GOOD BLOOD RETURN WAS OBSERVED, AND BOTH PORTS FLUSHED EASILY. THE LINE WAS PLACED IN THE RIGHT BASILIC VEIN TO 35CM. PLACEMENT WAS CONFIRMED VIA X-RAY. THE PATIENT DEVELOPED THROMBUS TWO DAYS LATER IN THE BASILIC, AXILLARY AND SUBCLAVIAN VEINS ON THE RIGHT SIDE.
Bard Access Systems/Intravascular Catheter Lot: REPL0688 PICC NURSE INSERTED THE LINE TO 38CM INTO THE RIGHT BASILIC VEIN. GOOD BLOOD RETURN FROM BOTH PORTS WAS OBSERVED, AND BOTH PORTS FLUSHED EASILY. POSITION CONFIRMED VIA X-RAY. PATIENT DEVELOPED THROMBUS TWO DAYS LATER.
Bard Access Systems/Intravascular Catheter Lot: REQCO591 PICC NURSE INSERTED THE LINE INTO THE RIGHT MEDIAL CEPHALIC VEIN. THE PATIENT DEVELOPED A THROMBUS TO THE RIGHT SUBCLAVIAN, AXILLARY AND BRACHIAL VEINS TWO DAYS LATER. THE PICC LINE HAD BEEN INSERTED WITHOUT DIFFICULTY TO 40CM. GOOD BLOOD RETURN WAS NOTED UPON INSERTION, AND THE LINE FLUSHED EASILY. X-RAY CONFIRMED GOOD PLACEMENT.
Bard Access Systems/Intravascular Catheter Lot: REQH0324 PICC NURSE INSERTED THE LINE TO THE MIDLINE IN THE LEFT BASILIC VEIN, WHICH WAS APPROXIMATELY 17CM, WITHOUT DIFFICULTY. EXCELLENT BLOOD RETURN WAS OBSERVED AND BOTH PORTS FLUSHED EASILY. THE PATIENT DEVELOPED LEFT BRACHIAL VEIN THROMBUS TEN DAYS LATER.
Bard Access Systems/Intravascular Catheter Lot: REQG0213 PATIENT DEVELOPED A THROMBOSIS IN THE CEPHALIC, BASILIC, RADIAL AND ULNAR VEINS IN THE LEFT ARM TWELVE DAYS AFTER THE PICC LINE WAS INSERTED. NURSING STAFF DID NOT SAVE THE DEVICE OR THE PACKAGING. LINE INSERTED BY PICC RN WITHOUT DIFFICULTY TO 45CM. LINE FLUSHED EASILY AND HAD GOOD BLOOD RETURN. POSITION WAS CONFIRMED WITH X-RAY AND THE GUIDEWIRE WAS REMOVED PRIOR TO USE.
Bard Access Systems/Intravascular Catheter Lot: REQC0571 PICC NURSE INSERTED THE LINE TO 45CM INTO THE LEFT BASILIC VEIN. THE LINE HAD EXCELLENT BLOOD RETURN, AND BOTH PORTS FLUSHED EASILY. PLACEMENT WAS CONFIRMED VIA X-RAY. THE PATIENT DEVELOPED THROMBOSIS FIVE DAYS LATER.
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available INTERVENTIONAL RADIOLOGIST MD INSERTED PICC LINE UNDER ULTRASOUND FLUOROSCOPY TO THE LEFT BRACHIAL VEIN AND THREADED TO 38CM. PLACEMENT CONFIRMED UNDER FLUOROSCOPY. GOOD BLOOD RETURN AND BOTH PORTS FLUSHED WELL. MD FLUSHED PORTS WITH HEPARINIZED SALINE. UNKNOWN CONCENTRATION OF HEPARIN FLUSH. PT DEVELOPED THROMBOSIS ONE DAY LATER. RADIOLOGIST DID NOT RECORD ANY DEVICE IDENTIFYING INFORMATION. NO PACKAGING WAS SAVED AND STAFF DISPOSED OF THE DEVICE. IT IS UNCLEAR IF THE THROMBOSIS IS RELATED TO THE PICC LINE.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 6212018 A PT WITH EXTERNAL JUGULAR PICC LINE WAS DIFFICULT TO FLUSH. THE PT NEEDED TO SIT UP TO BREATHE. PICC WAS BEING REMOVED BECAUSE INABILITY TO DRAW BLOOD. STAFF NOTED CATHETER HUB HAD PULLED PARTIALLY OUT OF THE CATHETER UPON WITHDRAWAL.
Bard Access Systems/Intravascular Catheter Lot: 0909 REQ 100565N PATIENT'S PICC CATHETER CRACKED AT THE RED HUB. IT HAD BEEN FOR SEVERAL MONTHS AND WAS SCHEDULED TO BE CHANGED. IT WAS CHANGED OVER A WIRE WITH NO PROBLEMS. THE PATIENT WAS NOT HARMED.
Boston Scientific Corporation/Intravascular Catheter Lot: 1158324 WHEN THE RN WENT TO FLUSH THE PICC LINE PRE- MEDICATION SHE NOTICED THE BROWN PORT/HUB WAS MISSING FROM THE LUMEN. PICC LINE WAS REMOVED AND NEW ONE WAS INSERTED.
Boston Scientific Corporation/Intravascular Catheter Lot: 1185301 THE PATIENT WAS COMPLAINING OF PAIN FROM THE PICC LINE, A 5.0 FRENCH DOUBLE LUMEN CATHETER. EDEMA WAS NOTED TO BE IN RIGHT UPPER ARM AT APPROXIMATELY 5 INCHES. BOTH PIPERCILLIN AND SOLUMEDROL WERE INFUSING THROUGH THE CATHETER AT THE TIME OF THE INCIDENT. THE PICC LINE WAS DISCONTINUED AFTER A SMALL HOLE WAS FOUND. THE CATHETER LEAKED AT THE HOLE WHEN IT WAS FLUSHED. AN AQUA K-PAD WAS APPLIED TO THE ARM FOR COMFORT.
MEDCOMP/Intravascular Catheter Lot: MAJP9900 A 5FR PICC WAS BEING PLACED AND ADVANCED OVER .018 WIRE THROUGH A 5 FRENCH PEEL-AWAY SHEATH,THE PEEL-AWAY
PORTION DETACHED FROM THE HUB AND WAS PUSHED INTO THE VEIN ALONG WITH THE PICC. THE WIRE WAS LEFT IN THE PATIENT. THE PATIENT'S RIGHT GROIN WAS PREPPED AND THE PHYSICIAN SNARED THE SHEATH VIA THE RIGHT GROIN WITH NO COMPLICATION. PRE-SNARE AND POST-SNARE FILMS WERE TAKEN. A CALL WAS PLACED TO THE VENDOR ABOUT THE INCIDENT. VENDOR WAS TO CONTACT MANUFACTURER. THE HUB WAS SAVED FOR ANALYSIS.
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available THE PATIENT WENT INTO CARDIOPULMONARY ARREST AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED. DURING THE CODE, IT WAS SUSPECTED THAT THE PICC LINE BECAME INFILTRATED. AFTER THE CODE, THE PICC LINE WAS REMOVED, AND IT WAS
NOTED THAT LINE WAS BROKEN.
Becton Dickinson/Intravascular Catheter Lot: 7030302 THE STAFF FOUND THE PICC LINE COMPLETELY SEVERED JUST BELOW THE STABILIZING WINGS OF THE DEVICE. THE REMAINING TAIL OF THE PICC LINE WAS LEFT IN THE PATIENT. THE NEONATOLOGIST WAS NOTIFIED AND WAS ABLE TO REMOVE THE REMAINING PORTION OF THE LINE WITHOUT DIFFICULTY OR COMPLICATION AT THE BEDSIDE. A PERIPHERAL IV WAS THEN ESTABLISHED. NO HARM CAME TO THE PATIENT. THE DOCTOR DISCARDED THE INDWELLING PORTION OF THE PICC LINE; HOWEVER, THE TOP PORTION OF THE DEVICE IS AVAILABLE IN THE RISK MANAGEMENT DEPARTMENT. THE PICC LINE WAS INSERTED FIVE DAYS PRIOR BY A NURSE TRAINED IN INSERTING SUCH LINES. NO DIFFICULTIES WITH THE MAINTENANCE OF THE LINE WERE REPORTED FROM THE TIME OF INSERTION UP UNTIL THE LINE WAS FOUND TO BE SEVERED. IT REMAINS UNKNOWN HOW THE LINE BECAME SEVERED. STAFF REPORTED THAT THIS IS THE SECOND TIME THEY HAVE SEEN THIS HAPPEN IN THE LAST THREE MONTHS.
Arrow International, Inc./Intravascular Catheter Lot: RF7018265 DURING WIRE REMOVAL THERE WAS NOISE AND TENSION CHANGED. PATIENT WAS HAVING PICC LINE PLACED FOR ANTIBIOTIC THERAPY. "PING SOUND" AND OUTER SHEATH OF WIRE SEPARATED. ENTIRE WIRE/SHEATH REMOVED FROM PATIENT. NO HARM TO PATIENT.
Cook Medical/Intravascular Catheter Lot: 1882268 THE YELLOW HUB OF PICC LINE LEAKED. STAFF NEEDED TO CHANGE THE LINE DUE TO THE LEAK. THE PATIENT WAS NOT HARMED AS A RESULT OF THIS EVENT.
Bard Access Systems/Intravascular Catheter Device identifiers unknown/not available THE PATIENT HAD A PICC LINE PLACED WITH NO RESISTANCE. THERE WAS AN UNUSUAL KINK NOTED AT THE END OF THE PICC LINE BUT THE PICC LINE WORKED FINE. THE TIP WAS DRAWN BACK 1 CM. THIS PICC LINE WAS PLACED IN SAME VESSEL AS AN INTRAJUGULAR (IJ) LINE. THE IJ LINE WAS THEN REMOVED. TWO DAYS LATER PATIENT CODED. SUSPICION THAT INSERTION OR REMOVAL OF IJ LINE CAUSED PERFORATION OF SUPERIOR VENA CAVA (SVC).
Bard Access Systems/Intravascular Catheter Device Identifier Unknown/Not Available PATIENT NOTED TO HAVE SWELLING IN THEIR RIGHT ARM AS WELL AS RASH POSSIBLY DUE TO AN ALLERGIC REACTION TO CEFAZOLIN. A 4.0 FR, 18G PICC, SINGLE LUMEN CATHETER # RERB0508 WAS INSERTED INTO THE RIGHT BASILIC VEIN. THE TIP WAS LOCATED IN THE SUPERIOR VENA CAVA (SVC). ACUTE AXILLARY VEIN DVT WAS CONFIRMED BY A SCAN. THE PATIENT WAS SENT TO THE ER FOR ASSESSMENT AND A PRESCRIPTION OF ANTICOAGULANTS.
Becton Dickinson/Intravascular Catheter Lot: 6156083 PATIENT WAS IN A HYPERBARIC CHAMBER UNDERGOING PRESSURIZED OXYGEN THERAPY WHEN THE INSIDE OBSERVER REPORTED A DISLODGED MIDLINE. THE MIDLINE HAD BEEN INSERTED IN THE LEFT UPPER EXTREMITY TWO DAYS PRIOR TO THE HYPERBARIC TREATMENT. THE RN NOTED THAT, UPON INSPECTION, THE DISTAL END OF THE CATHETER WAS HANGING FREELY AND THE PROXIMAL PORTION WAS STILL IN THE PATIENT'S ARM. THE ENTIRE CATHETER WAS REMOVED. UPON INSPECTION ALL 20 CM WAS REMOVED. THE PATIENT APPEARED TO HAVE NO ADVERSE EFFECTS.
Bard Access Systems/intravascular Catheter Lot: RERE 02714FR PORTION OF GUIDE WIRE BROKE OFF AND WAS RETRIEVED. WIRE BROKE OFF DURING INSERTION OF PICC LINE INTO PT'S RIGHT ARM. WIRE WAS SEEN ON POST PROCEDURE CHEST X-RAY.
Bard Access Systems/Intravascular Catheter Lot: RERA 0778 THE PICC GUIDEWIRE WAS REMOVED FROM THE CATHETER, ONLY 6 INCHES PLUS OR MINUS. THE REMAINDER OF THE PICC CAME OUT WHEN THE GUIDEWIRE WAS REMOVED. IT DID NOT PULL OUT AS ONE UNIT.
Cook Medical/Intravascular Catheter Device Identifiers Unknown/Not Available THIS PICC LINE WAS PLACED AND THREE DAYS LATER A HOLE WAS DISCOVERED. PICC EXCHANGED OVER A WIRE FOR A NEW PICC. INSPECTION OF ORIGINAL PICC REVEALS A VERY SMALL HOLE AT THE PROXIMAL END OF THE "YELLOW" LUMEN. HOLE WAS THEN MARKED WITH MARKER. NO INJURY TO THE PATIENT.
Vygon Corporation/Intravascular Catheter Catalog: 2184.00 A PICC LINE WAS PLACED THROUGH THE SCALP VEIN FOR TPN ONLY. CORRECT PLACEMENT WAS CONFIRMED USING CONTRAST AND AN X-RAY. SUBSEQUENT DRESSING CHANGES BY THE NURSES DOCUMENTED THE LENGTH OF THE CATHETER EXTERNAL TO THE SCALP HAD NO CHANGES. TWO MONTHS LATER THE CHILD WAS WORKED UP FOR SEPSIS. NO BLOOD COULD BE WITHDRAWN FROM PICC FOR CULTURE AND SENSITIVITY (C&S). CONTRAST WAS INJECTED TO CONFIRM THE PLACEMENT OF THE LINE IT WAS DISCOVERED THAT THE PICC WAS COILED IN THE LEFT SIGMOID SINUS.
Becton Dickinson/Intravascular Catheter Lot: 7031548 PICC LINE WAS PLACED IN THE LEFT ANTERIOR SAPHENOUS VEIN. THE PICC LINE WAS FOUND BROKEN OFF JUST BELOW THE HEART. TPN WAS INFUSING THROUGH THE LINE AT THE TIME OF THE EVENT. THE REMAINDER OF THE LINE WAS REMOVED FROM THE PATIENT INTACT.
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available AFTER SUCCESSFULLY FLUSHING THE RIGHT UPPER EXTREMITY HANGING ANTIBIOTICS AND PICC LINES, THE PATIENT CALLED THE NURSE BACK INTO ROOM 20 MINUTES LATER. UPON ENTERING THE ROOM, THE NURSE FOUND THE PATIENT WITH BLOOD ALL OVER THEIR GOWN AND RIGHT UPPER EXTREMITY. THE NURSE IMMEDIATELY APPLIED PRESSURE. WHEN SHE REMOVED THE BANDAGE, SHE FOUND THE BLUE PORTION OF THE PICC LINE HAD BROKEN IN HALF. THE WHITE AND RED PARTS WERE STILL CONNECTED TO HALF OF THE CATHETER. A STAT CHEST X-RAY WAS ORDERED WHICH SHOWED 20 CM OF THE CATHETER REMAINING IN RIGHT UPPER EXTREMITY GOING INTO THE RIGHT VENTRICLE. THE PATIENT, WHO HAD STABLE VITAL SIGNS, WAS PREPPED FOR THE REMOVAL PROCEDURE. THE PICC FRAGMENT EXTENDED FROM THE RIGHT AXILLARY VEIN TO THE RIGHT VENTRICLE. A SNARE WAS ADVANCED AND USED TO GRASP THE PICC FRAGMENT. BOTH THE PICC FRAGMENT AND THE SHEATH WERE REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE COMPLICATIONS. THE LOT AND SERIAL NUMBERS ARE NOT AVAILABLE FOR THIS DEVICE.
Bard Access Systems Lot: RERE0065 PATIENT CAME TO CLINIC COMPLAINING OF PAIN IN HIS LEFT ARM STARTING AT HIS ELBOW AND RADIATING TO HIS SHOULDER. PATIENT DID NOT HAVE ANY SWELLING SIGNS OR SYMPTOMS OF INFECTION AT SITE. MDS PAGED AND ORDERED PICC TO BE REMOVED. DOPPLER STUDIES ORDERED AND PATIENT WAS FOUND TO HAVE A DVT. PATIENT WAS SENT TO ER FOR TREATMENT. PICC PLACED BY VASCULAR APPROXIMATELY ONE MONTH PRIOR.(5 FR., 18 G, DOUBLE LUMEN, POWER PICC).
Bard Access Systems/Intravascular Catheter Lot: RERC0446 IV TEAM NURSES ENCOUNTERED DIFFICULTY INSERTING A PICC LINE INTO PATIENT. THE GUIDELINE "SPLIT" AND BEGAN TO UNRAVEL AND A PORTION OF THE WIRE WAS LEFT IN THE PATIENT. THE WIRE HAD TO BE SURGICALLY REMOVED THE NEXT DAY. PATIENT DID NOT EXPERIENCE ANY FURTHER UNTOWARD EFFECTS.
Becton Dickinson/Intravascular Catheter Lot: 7039277 PATIENT HAD PICC LINE IMPLANTED. APPROXIMATELY, A MONTH LATER CHEST X-RAY REVEALED THAT THE PICC LINE HAD BROKEN. PATIENT TRANSFERRED TO ANOTHER MEDICAL FACILITY TO HAVE PICC LINE EXPLANTED. FOLLOW UP CONDITION NOT KNOWN AT THIS TIME.
Arrow International, Inc./Intravascular Catheter Lot: RF7065441 PICC PLACED BUT UNABLE TO REMOVE WIRE WITHOUT IT BREAKING, SO WIRE AND CATHETER WERE REMOVED AS ONE UNIT. PICC WITH DIFFERENT LOT NUMBER PLACED OTHER ARM WITHOUT INCIDENT.
Boston Scientific Corporation/Intravascular Catheter Lot: 1210616 THE PATIENT HAD A PICC PLACED IN THE RIGHT ARM FOR ADMINISTRATION OF IV ANTIBIOTICS TO TREAT AN INFECTION IN THE LEFT FOREARM. AFTER PLACEMENT OF THE PICC, MEDICATIONS WERE ADMINISTERED. LATER IN THE DAY, IT WAS FOUND THAT THE HUB HAD SEPARATED FROM THE CATHETER. THE PICC WAS PULLED AND A NEW ONE WAS PLACED THE NEXT DAY.
Becton Dickinson/Intravascular Catheter Lot: 7121701 THE BEDSIDE NURSE ASKED THE TRANSPORT NURSE (PICC "TEAM" MEMBER) TO CHANGE THE PICC DRESSING, WHICH HAD LOOSENED. THE CHEST X-RAY SHOWED THAT THE LINE WAS NO LONGER CENTRAL. THE TRANSPORT NURSE ATTEMPTED TO RE-THREAD A NEW LINE. WHILE ATTEMPTING TO REMOVE THE OLD LINE CATHETER, IT BROKE WITH FIVE CM REMAINING IN THE PATIENT. THE PATIENT HAD TO HAVE THE LINE FRAGMENT REMOVED UNDER FLUOROSCOPY.
Bard Access Systems/Intravascular Catheter Lot: RERH0461 RN REPORTS WHILE PLACING A PICC LINE, THE SCISSORS, WHICH ARE INCLUDED IN THE KIT, WERE NOT SHARP ENOUGH TO CUT THE DOUBLE LUMEN PICC. THIS IS THE SECOND TIME THIS RN HAS ENCOUNTERED THIS PROBLEM. THE INCLUDED SCISSORS GNASHED THE PICC LINE MAKING IT IMPOSSIBLE TO GET A CLEAN CUT. BOTH TIMES THIS HAS HAPPENED THE RN HAS RESORTED TO USING THE BLADE FROM THE KIT TO CUT THE LINE. MANUFACTURER RESPONSE FOR DOUBLE LUMEN PICC KIT, BARD:MANUFACTURER WILL BE NOTIFIED BY MEANS OF THIS MEDWATCH. UNFORTUNATELY DEVICE WAS DISCARDED IN BOTH INCIDENTS. WE HAVE EDUCATED OUR STAFF ON RETAINING MALFUNCTIONED ITEMS FOR EVALUATION PURPOSES.
Bard Access Systems/Intravascular Catheter Catalog: RERF0742 ORDERS RECEIVED TO REMOVE PATIENT'S PICC LINE. PATIENT STATES THE LINE HAD BEEN BOTHERING HER. LEFT ARM WAS NOTED TO BE APPROXIMATELY TWICE THE SIZE OF THE RIGHT. PHYSICIAN NOTIFIED AND DOPPLER STUDIES WERE POSITIVE FOR DVT. PATIENT IS CURRENTLY ON COUMADIN
Cardinal Health Medical Products and Services/ Intravascular Catheter Catalog: 81450SG A SINGLE LUMEN POWER PICC WAS PLACED IN THE ARM OF THE PATIENT. THE SCISSORS, PROVIDED IN THE PRESOURCE INSERTION KIT, WERE TOTALLY BLUNT (DULL). THEY WOULD NOT CUT THE PICC CATHETER AND ALSO DID NOT CUT A PLASTIC SHEATH WHEN TESTED LATER. RN RESORTED TO CUTTING THE PICC WITH A KNIFE BLADE AND HAD TO MAKE THE PICC 1 CM SHORTER TO OBTAIN A CLEAN CUT.
Bard Access Systems/Intravascular Catheter lot: RERE0505 A PICC LINE WAS INSERTED MID YEAR OF 2007. A POST-PROCEDURE X-RAY REVEALED GOOD POSITION. FOLLOW-UP X-RAYS OF TWO WEEKS AND THREE MONTHS LATER SHOW A 4 CM WIRE SOMEWHERE IN THE LEFT LOWER LOBE.
Bard Access Systems/Intravascular Catheter Lot: RER10771 THE PICC NURSE WAS CALLED TO INSERT A PICC LINE FOR A PATIENT SCHEDULED TO RECEIVE LONG TERM IV ANTIBIOTICS. THE PICC WAS INSERTED WITHOUT ANY DIFFICULTY. HOWEVER, IMMEDIATELY AFTER INSERTION, A LEAK WAS NOTED ON THE TOP PORTION OF THE PICC LINE BY THE WINGS. UPON CLOSER INSPECTION, A SMALL SLIT LENGTHWISE IN THE TIP PORTION OF THE PICC NEXT TO THE WINGS WAS NOTED. PRIOR TO INSERTION, STAFF DID NOT SEE A SLIT. HOWEVER, THE PICC RN EXPLAINED THAT THIS IS AN UNUSUAL PLACE TO FIND A SLIT AND THAT PICC STAFF WOULD NOT ROUTINELY LOOK CLOSELY AT THIS AREA OF THE DEVICE PRIOR TO INSERTION. ALL OTHER ASPECTS OF VISUAL INSPECTION PRIOR TO INSERTION FOUND NO DEFECTS. THE REP WAS CONTACTED BY STAFF AND THE DEVICE WAS RETURNED TO HER. THE LEAKING PICC LINE WAS REMOVED AND THE PICC RN ATTEMPTED TO DO AN EXCHANGE, WHICH WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO RADIOLOGY, WHERE AN INTERVENTIONAL RADIOLOGIST PLACED A PICC LINE WITH THE ASSISTANCE OF FLUOROSCOPY.
Cardinal Health Medical Products and Services/Intravascular Catheter Model: 81450SG OUR PICC TEAM HAS HAD AN ONGOING ISSUE WITH THE SCISSORS CONTAINED WITHIN THE CARDINAL HEALTH PICC KITS. THESE WERE EARLIER REPORTED AS BELONGING TO A DIFFERENT MANUFACTURER (1 PAIR) HOWEVER ON FURTHER RESEARCH WE HAVE CONFIRMED THESE SCISSORS ARE MANUFACTURED BY SURGICAL DESIGN INSTRUMENTS. OUR PICC NURSES HAVE REPORTED THESE SCISSORS WILL NOT CUT THE PICC LINE IN THE KIT THESE ARE PART OF. THE NURSES HAVE HAD TO RESORT TO USING A SCALPEL WHICH IS ALSO INCLUDED IN THE KIT. PICC LINES NEED TO HAVE A PRECISE CLEAN EDGE,THESE SCISSORS HAVE BEEN GNASHING THE LINE. THESE ARE PART OF A PICC LINE PLACEMENT KIT WE PURCHASE THROUGH CARDINAL HEALTH. OUR REP HAS ARRANGED FOR THESE SCISSORS TO BE SWITCHED OUT TO A DIFFERENT SCISSOR. I DO HAVE 3 PAIRS FOR EVALUATION PURPOSES.
BD Infusion Therapy Systems, Inc./Intravascular Catheter PEDIATRIC CENTRAL VENOUS LINE ("PCVL") IN RT ARM. ALARM SOUNDED "DISTAL OCCLUSION"; IV RATE INCREASED SLIGHTLY-STILL ALARMED. FILTER CHANGED UNDER STERILE CONDITIONS-AFTER 10 MINS ALARMED AGAIN "DISTAL OCCLUSION." MD FLUSHED 3MLS N/S FROM CLOSEST DISTAL PORT, AND 2 PINHOLES WERE SEEN WHERE FLUID LEAKED. PEDIATRIC IV INSERTED; PCVL PULLED OUT.
Bard Access Systems/Intravascular Catheter Catalog: 3164155 PICC LINE WAS FOUND TO BE LEAKING AT THE HUB; WAS REPLACED.
Advanced Medical, Inc./Intravascular Catheter Lot: MAMN530 NURSE WAS FLUSHING PICC LINE WHEN IT WAS NOTED THAT THE PICC LINE WAS LEAKING AT THE HUB. THE PATIENT WAS TAKEN TO RADIOLOGY WHERE THE PATIENT WAS SEDATED. THE PHYSICIAN REMOVED THE OLD PICC LINE. THE REMOVAL CONSISTED OF AN OVER WIRE PROCEDURE. THE SAME VASCULAR ACCESS POINT WAS UTILIZED FOR THE NEW PICC LINE (RIGHT POPLITEAL VEIN).
Becton Dickinson/Intravascular Catheter Lot:7039277 NEWLY INSERTED PICC LINE DISLODGED WHEN IT WAS BEING REPOSITIONED. SEVEN CM OF THE CATHETER REMAINED INSIDE THE PATIENT REQUIRING SURGICAL RETRIEVAL AND THE NEED FOR A CENTRAL LINE TO BE PLACED.
Becton Dickinson/Intravascular Catheter Device Identifiers Unknown/Not Available PATIENT WAS IN THE NICU WITH A PICC LINE. THE NURSE ENTERED THE ROOM AND OBSERVED THAT THE LINE HAD BROKEN AT THE HUB. THE REMAINING CATHETER WAS REMOVED WITHOUT INJURY TO THE PATIENT.
HDC Corporation/Intravascular Catheter Lot: 4FR 1026, 1029, 1030; 5FR 1033 THERE HAVE BEEN MULTIPLE PROBLEMS WITH THE INTRODUCER KITS THAT REQUIRE THE SELDINGER TECHNIQUE. THEY FALL INTO THREE GROUPS:
1) LEADING EDGE OF PEEL-AWAY INTRODUCER IS FLARED WHICH WOULD LIKELY CAUSE INJURY IF PUSHED INTO A VEIN (HAVE SEEN TWICE).
2) TIP OF DILATOR WON'T ALLOW GUIDEWIRE TO PASS. (THIS HAS HAPPENED AROUND FOUR TIMES TO SEVERAL IV NURSES, BUT VISUAL INSPECTION OF KITS REVEALS A NON-CIRCULAR OPENING IN ABOUT 15% OF DILATORS.) THIS RESULTS IN A COMPLETE REDO OF INSERTION WHICH CAN BE DIFFICULT ON SOME PATIENTS.
3) HANDLE ON END OF GUIDEWIRE CAME OFF SO THAT WIRE COULD NOT BE REMOVED PROPERLY (OCCURRED ONCE). THIS REQUIRED A SECOND INSERTION THROUGH THE EXISTING INTRODUCER.
PROBLEM 1) NO RESPONSE YET.
PROBLEM 2) PROBLEMATIC DILATORS COME FROM A COMPANY CALLED ENPATH. HDC HAS SENT DILATORS FROM A DIFFERENT COMPANY. THEY FUNCTION THE SAME WAY. REPORTEDLY, HDC DOESN'T MANUFACTURE THE DILATORS. THEY BUY THEM FROM THIRD PARTIES: ENPATH AND OTHERS.THE ENPATH DILATORS WERE THE ONES THAT WERE HAVING THE PROBLEMS. ANOTHER COMPANY'S WERE OFFERED AS REPLACEMENTS SO THAT THE EXISTING KITS COULD STILL BE USED. THEY COME IN INDIVIDUAL STERILE PACKS.
Bard Access Systems/Intravascular Catheter lot: RERD0689 AT THE COMPLETION OF PICC PLACEMENT, WIRE STYLET BECAME SEPARATED/UNRAVELED DURING REMOVAL. ENTIRE WIRE REMOVED WITH DISTAL (4 CM) TIP INTACT BUT PROXIMAL END AND REST OF WIRE SEPARATED. PICC THEN REMOVED AS IT WOULD NOT FLUSH AFTER WIRE REMOVED, NO RESISTANCE TO REMOVAL, CATH INTACT.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 7250110 THE PATIENT WAS SCHEDULED FOR A CT SCAN. WHILE IN RADIOLOGY, THE TECH FLUSHED THE PICC WITH 1 ML OF NORMAL SALINE THROUGH LONGEST PORT VIA A 10ML SYRINGE. CONTRAST DYE WAS THEN ADMINISTERED VIA A 10ML SYRINGE. FOUR OF SEVEN ML OF DYE GIVEN. PICC THEN BURST AT THE HUB. NO BLEEDING BACK NOTED. FLUIDS STOPPED, INFANT RETURNED TO NCCC. NNP NOTIFIED IMMEDIATELY. PICC REMOVED. CATHETER APPEARED INTACT.
Boston Scientific Corporation/Intravascular Catheter Lot: 1224626 SEVEN PICC LINES HAVE BEEN IDENTIFIED AS APPARENTLY DEFECTIVE AS PATIENTS HAVE RETURNED DUE TO LEAKING. FOUND ALL HAVE A CRACK IN LEG OF CATHETER. REMOVED AND REPLACED WITH NEW LINE.
Bard Access Systems/Intravascular Catheter Lot: RERL0475 THE NURSE FOUND THAT THE PICC LINE CATHETER HAD FRACTURED AT THE HUB, AND WAS LYING IN THE BED WITH THE OTHER PART OF THE CATHETER STILL IN THE PATIENT. THE PORTION OF THE CATHETER THAT WAS STILL IN THE PATIENT WAS REMOVED WITH THE TIP INTACT. THIS PICC LINE WAS PLACED 16 DAYS PRIOR VIA ULTRASOUND AND FLUOROSCOPIC GUIDED PLACEMENT IN THE RIGHT ANTECUBITAL.
Bard Access Systems/Intravascular Catheter Catalog: 3386105 UPON PLACING A PICC LINE, THE INTERNAL WIRE COIL FRAYED WHEN IT WAS REMOVED FROM PATIENT'S RIGHT ARM AND POSSIBLY LEFT BEHIND A FOREIGN BODY WIRE IN THE ARM.
Bard Access Systems/Intravascular Catheter Lot: RESC0612 THE ORDER WAS RECEIVED FOR A PICC PLACEMENT, AND THE ROUTINE PREPARATION PER PROTOCOL WAS COMPLETED. THE RIGHT BRACHIAL VEIN WAS ACCESSED UNDER ULTRASOUND GUIDANCE. THE GUIDEWIRE WAS ADVANCED THROUGH THE NEEDLE. THE NEEDLE WAS REMOVED, HOWEVER, WHEN THE STAFF MEMBER ATTEMPTED TO REMOVE THE GUIDEWIRE FROM THE PATIENT'S ARM, RESISTANCE WAS MET AND THE WIRE WAS UNABLE TO BE REMOVED. AFTER FURTHER ATTEMPTS TO REMOVE THE GUIDEWIRE, IT UNRAVELED. THE WIRE WAS EVENTUALLY REMOVED, AND PRESSURE WAS HELD AT THE SITE. AN X-RAY OF THE RIGHT ARM WAS COMPLETED TO ASSESS IF ANY RESIDUAL WIRE REMAINED IN THE PATIENT. REVIEW OF FILMS DETERMINED THERE WERE NO FOREIGN BODIES PRESENT. THE PATIENT WAS REFERRED TO INTERVENTIONAL RADIOLOGY FOR LINE PLACEMENT. THE PHYSICIAN WAS CONSULTED, AND NO RIGHT ARM FOLLOW-UP WAS NEEDED.
Bard Access Systems/ Intravascular Catheter Lot: RERJ0658 THE RN ENTERED THE PATIENT'S ROOM AND FOUND THE PICC LINE BROKEN APPROXIMATELY ONE INCH BELOW THE PICC SECURE WINGS. STAFF REPORT THAT APPROXIMATELY THREE INCHES REMAINED UNDER THE TEGADERM, SECURED TO THE SKIN. THE PICC LINE WAS CLAMPED AND THE PICC RN WAS NOTIFIED. THE PICC LINE WAS THEN REMOVED AND A NEW LINE INSERTED. NO PATIENT HARM. THE PICC LINE HAD BEEN PLACED IN THE LEFT BASILIC VEIN WITHOUT DIFFICULTY BY THE PICC NURSE. OUR FACILITY'S PRACTICE IS TO FLUSH PICC LINES WITH SALINE ONLY USING A 6CC OR LARGER SYRINGE BEFORE AND AFTER IV PUSH MEDS AS WELL AS BLOOD DRAWS. THE PORTS ARE CLEANED WITH CHLORHEXIDINE.
Bard Access Systems/ Intravascular Catheter Lot: RERI0505 PICC RN EVALUATING PICC LINE FOR PATIENT AND NOTED THAT THE LINE WAS LEAKING. AFTER REMOVING THE TEGADERM DRESSING, SHE FLUSHED THE WHITE PORT OF THE PICC LINE WITH 0.9 NORMAL SALINE AND NOTED A SALINE STREAM SHOOTING FROM THE PICC LINE AT 53CM. SHE FLUSHED THE RED PORT AND NOTED SOME SALINE LEAKING FROM THE SAME AREA. WHEN THE CATHETER EXCHANGE WAS UNSUCCESSFUL, A NEW LINE WAS INSERTED. OUR FACILITY'S PRACTICE IS TO FLUSH THE SYRINGE WITH 5-10CC OF SALINE AFTER EVERY USE OF THE PICC, INCLUDING MEDS AND LAB DRAWS. THE PORTS ARE CLEANED WITH CHLORHEXIDINE PRIOR TO ACCESS.
Bard Access Systems/Intravascular Catheter Lot: RERJ0460 PICC LINE PLACEMENT DONE PER PICC RN WITH 5 FRENCH DUAL LUMEN CATHETER WITH GOOD BLOOD RETURN AND BOTH PORTS FLUSHED WELL. 34 CM INSERTED WITH 11 CM REMAINING OUT. PLACEMENT CONFIRMED BY CXR AND RADIOLOGIST. WHEN IRRIGATING CATHETER, THERE WAS LEAKAGE BY THE WINGS, FLOOR NURSE AND RADIOLOGIST ADVISED. PT SENT TO SPECIALS FOR INSERTION OF ANOTHER LINE.


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