MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM GUID; 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)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.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 connection seems to have something blocking the threads of the luer connection.The needle-free connector (nfc) that was being luered onto the picc is a baxter one-link.It was stated when they aspirated the picc, there were visible air bubbles.When the picc had been flushed, there was and a leak coming from the connection.

• Brand Name: POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM GUID
• 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: 10491607
• Report Number: 3006260740-2020-03164
• Device Sequence Number: 19613032
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070996
• 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): 09/03/2020

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: 3174155
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1