MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY

Catalog Number 3275135

Device Problems Retraction Problem (1536); Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2013

Event Type  malfunction  

Event Description

While trying to retract guidewire, it bound up.Once removed, it came unraveled and a piece came off in the picc, but not the pt.

Manufacturer Narrative

The device has not been returned to the mfr, at this time, for eval.A lot history review (lhr) of rexj0368 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY
• Manufacturer (Section D): C.R. BARD, INC. (BASD); salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilber ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015950700
• MDR Report Key: 3633817
• MDR Text Key: 4202531
• Report Number: 3006260740-2013-00545
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2013

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
• Device Operator: Health Professional
• Device Catalogue Number: 3275135
• Device Lot Number: REXJ0368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/27/2013
• Initial Date FDA Received: 01/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention