MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAY

Model Number	1274108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a tear in the extension leg near the hub was confirmed, but the exact cause of the damage was unknown.One 4fr d/l powerpicc sv was returned for investigation.The catheter exhibited evidence of use.A circumferential breach was observed in the purple extension leg just inside the distal end of the red connector.The cross section of the damaged extension leg was microscopically examined and was noted to be rough and jagged.The characteristics observed on the extension leg indicate that the tubing tore.The break in the extension leg could be attributable to pulling, twisting, and manipulating the luer adaptor.An annular wear pattern was observed in the extension leg that coincided with the distal end of the red connector.A semi-circumferential crease was observed 3mm distal to the location of the breach.The crease in the tubing indicates that the extension leg was kinked at that location.Due to the evidence of use, the damage may have developed over time.It was reported that the picc was placed (b)(6) 2017 and removed on (b)(6) 2018.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the catheter was removed due to break/separation where red hub connects to the extension leg.No injury was reported and a new line was placed successfully.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7516921
• Report Number: 3006260740-2018-00963
• Device Sequence Number: 1544933
• Product Code: LJS
• UDI-Device Identifier: 00801741086908
• UDI-Public: (01)00801741086908
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: 1274108
• Device Catalogue Number: 1274108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1