MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET (4F) (DUAL-; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu3017 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the polyurethane appeared to be torn at the suture wings.It caused the picc to leak and the dressing was soiled a day after the dressing was changed and that is how it was noted to be leaking.They had previously reported an occlusion and had treated it for that.
Event or Problem Description
It was reported that the polyurethane appeared to be torn at the suture wings.It caused the picc to leak and the dressing was soiled a day after the dressing was changed and that is how it was noted to be leaking.They had previously reported an occlusion and had treated it for that.
Additional 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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed and the cause appeared to be associated with use.One 4fr dual-lumen (d/l) powerpicc sv was returned for investigation.The catheter exhibited evidence of use.Non-vad injection caps were attached to the connectors.Material that was consistent with tape residue was observed on the extension legs and bifurcation.The catheter extended 9mm beyond the 13cm depth mark.A microscopic examination revealed a tear in the bifurcation at the proximal end of each wing.One tear exposed the non-power injectable lumen.The adjoining surfaces of the torn material were smooth and granular.A functional test revealed that the lumens were patent to infusion.When water was flushed through the lumen with the white connector (non-power injectable), fluid leaked from the tear at the bifurcation and wing.No fluid leaked from the power injectable lumen.Manipulation of the catheter, for example, pulling or twisting the wings can cause the material to tear.Due to the evidence of use, it appeared that the tear developed over time.It was reported that the leak was observed a day after the dressing was changed.A lot history review (lhr) of redu3017 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET (4F) (DUAL-
• Common Device Name: 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 Key: 9655439
• Report Number: 3006260740-2020-00364
• Device Sequence Number: 16833135
• Product Code: LJS
• UDI-Device Identifier: 00801741028625
• UDI-Public: (01)00801741028625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9274108
• Device Lot Number: REDU3017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1