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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC T; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC T; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problems Bacterial Infection (1735); Edema (1820); Unspecified Infection (1930)
Event Date 11/02/2019
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recp1655 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was informed that "it was scheduled catheter removal due to left upper limb edema, local pain, hyperemia, hyperemia, and bacteremia.Catheter implanted 3 months ago.Patient using vancomycin + home hydration.Inserted 51cm and sent part for culture.Sending for analysis catheter with 46 cm and a crack of 2cm - 24 to 26 cm.High risk of ruptured catheter inside the patient." 11/22/2019 - customer has sent additional information by e-mail: a 51 cm was inserted in the patient, but 46cm was sent for analysis because the tip was cut for catheter tip collection, as reported.The tip was submitted to microbial analysis - results: negative.Patient had significant edema in the limb where the catheter was inserted, increased stretch marks on the skin, local pain.It was opted to withdraw the device and so it was identified a crack in the catheter.Another central venous catheter was inserted in "scd".This is a patient with severe myelomeningocele sequelae, with poor prognosis, remaining unstable, worsening of the general condition in the last week and worsening of the general exams.Keeps hospitalized at home by family choice.11/27/2019 - customer has sent additional data: it was necessary to be hospitalized for removal of the picc because the patient was hospitalized via home care, so he went to the hospital for removal and for the passage of cvc - central venous catheter in right subclavian scd.There was no need for any medication, only the antibiotic was changed.It was needed local anesthesia for catheter change.The edema did not compromise any organism function, the limb is being but still with edema observed.
 
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, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter rupture was confirmed and the cause appears to be use related.The product returned for evaluation was one 4 fr powerpicc solo catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed near the 25 cm depth marker.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: longitudinal split.Tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).The catheter material was visibly lighter in color at the fracture site.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product and the catheter wall thickness was found to be within specification.A lot history review (lhr) of recp1655 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was informed that "it was scheduled catheter removal due to left upper limb edema, local pain, hyperemia, hyperemia, and bacteremia.Catheter implanted 3 months ago.Patient using vancomycin + home hydration.Inserted 51cm and sent part for culture.Sending for analysis catheter with 46 cm and a crack of 2cm - 24 to 26 cm.High risk of ruptured catheter inside the patient." 11/22/2019 - customer has sent additional information by e-mail: a 51 cm was inserted in the patient, but 46cm was sent for analysis because the tip was cut for catheter tip collection, as reported.The tip was submitted to microbial analysis - results: negative.Patient had significant edema in the limb where the catheter was inserted, increased stretch marks on the skin, local pain.It was opted to withdraw the device and so it was identified a crack in the catheter.Another central venous catheter was inserted in "scd".This is a patient with severe myelomeningocele sequelae, with poor prognosis, remaining unstable, worsening of the general condition in the last week and worsening of the general exams.Keeps hospitalized at home by family choice.11/27/2019 - customer has sent additional data: it was necessary to be hospitalized for removal of the picc because the patient was hospitalized via home care, so he went to the hospital for removal and for the passage of cvc - central venous catheter in right subclavian scd.There was no need for any medication, only the antibiotic was changed.It was needed local anesthesia for catheter change.The edema did not compromise any organism function, the limb is being but still with edemaobserved.
 
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Brand Name
POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC T
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9447865
MDR Text Key170541814
Report Number3006260740-2019-03804
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741138980
UDI-Public(01)00801741138980
Combination Product (y/n)N
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/01/2020
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number4174118
Device Lot NumberRECP1655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Event Location Hospital
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received12/10/2019
Supplement Dates Manufacturer Received04/23/2020
Supplement Dates FDA Received05/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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