MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER W/SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET FULL TRAY; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	1274108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
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 device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Sample was discarded by the facility.
Event or Problem Description
Facility contacted the sales rep whereby they asked if they could run a wire through either port, of the sv picc line for exchange.The sv picc began to leak out on the proximal hub past the clamp.No patient injury was reported.

• Brand Name: POWERPICC SV CATHETER W/SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET FULL TRAY
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6965129
• Report Number: 3006260740-2017-01868
• Device Sequence Number: 1117814
• Product Code: LJS
• UDI-Device Identifier: 00801741086908
• UDI-Public: (01)00801741086908
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1