MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rees0340 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "we had a recent incident with the powerglide pro midline catheter that needs to be reported for investigation as the tip broke off in the patient." add info rcvd 09/29/2020: during attempt to insert midline to lue cephalic vein, the catheter was slowly advanced but resistance was felt right away.Pt also complained of pain.Immediately, the entire midline unit was removed from patient¿s arm.Upon assessment of midline needle, it was found that approximately 1 cm of the catheter was missing.Catheter was able to be visualized by this rn within arm tissue using ultrasound machine.Pressure was applied with gauze to the needle insertion site and the tourniquet was left in place.The primary rn was informed right away, as well as the attending md consulted ir for recommendation.Within a few minutes, dr.Returned phone call and spoke to this rn regarding situation and quickly arrived to bedside to assess patient.Dr.Assessed patient¿s arm with ultrasound machine and confirmed 1 cm of catheter was visible within arm.Dr.Released the tourniquet and recommended obtaining a venous doppler study within 24 hours, and to leave the catheter tip where it was.".

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide catheter was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter.Usage residues were observed throughout the sample.The catheter terminated 8.8cm from the molded joint.The distal catheter fragment was not returned.The break in the catheter exhibited a tapered profile.Microscopic inspection of the break in the catheter revealed a partially granular and partially glossy fracture surface.A longitudinally aligned scoring mark was observed in the inside surface of the catheter, leading into the break site.The catheter fracture features were consistent with damage caused by contact with the introducer needle tip.Such damage can occur if the catheter is withdrawn onto the needle following advancement and if the needle is re-inserted into the catheter following advancement.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ h3 other text : evaluation findings are in section h.11.

Event Description

It was reported "we had a recent incident with the powerglide pro midline catheter that needs to be reported for investigation as the tip broke off in the patient." add info rcvd 09/29/2020: during attempt to insert midline to lue cephalic vein, the catheter was slowly advanced but resistance was felt right away.Pt also complained of pain.Immediately, the entire midline unit was removed from patient¿s arm.Upon assessment of midline needle, it was found that approximately 1 cm of the catheter was missing.Catheter was able to be visualized by this rn within arm tissue using ultrasound machine.Pressure was applied with gauze to the needle insertion site and the tourniquet was left in place.The primary rn was informed right away, as well as the attending md consulted ir for recommendation.Within a few minutes, dr.Returned phone call and spoke to this rn regarding situation and quickly arrived to bedside to assess patient.Dr.Stack assessed patient¿s arm with ultrasound machine and confirmed 1 cm of catheter was visible within arm.Dr.Released the tourniquet and recommended obtaining a venous doppler study within 24 hours, and to leave the catheter tip where it was." placement info: lue cephalic vein (attempted) what they¿re being treated for: unstable angina other relevant history: type 2 diabetes.

• Brand Name: FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10690487
• MDR Text Key: 211728680
• Report Number: 3006260740-2020-20142
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587
• Combination Product (y/n): N
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120108PT
• Device Lot Number: REES0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 96