MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebq2134 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the that picc line was leaking and the line needed to be exchanged or removed.Per notes in chart: (b)(6) 2018 vat called because dressing non-occlusive.Dressing changed and catheter found to be out 5 cm.Line flushed by bedside rn and catheter noted to be leaking.After speaking with providers line left in place (but not used) so a decision could be made to exchange of remove the line.After id consulted and iv antibiotics changed to po, the line was removed the next day.Almost a complete break in catheter noted at the point where the catheter joins to the wings.

• Brand Name: POWERPICC SV CATHETER
• 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: 7986115
• Report Number: 3006260740-2018-02966
• Device Sequence Number: 16515984
• Product Code: LJS
• UDI-Device Identifier: 00801741035531
• UDI-Public: (01)00801741035531
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: N/A
• Device Catalogue Number: 9173108D
• Device Lot Number: REBQ2134
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1