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

Catalog Number 3275355

Device Problems Break (1069); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/18/2013

Event Type  Injury  

Event Description

While placing a "pic" in pt, the wire got stuck in the axcela, and would not come out.It ended up shearing, and they had to snare the wire out of the pt.

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Results are expected soon.

• Brand Name: POWER PICC 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 gilbert ; 605 north 5600 west; salt lake city, UT 84116 ; 8015950700
• MDR Report Key: 3587197
• MDR Text Key: 22002920
• Report Number: 3006260740-2014-00005
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3275355
• Device Lot Number: REXJ1605
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/07/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/13/2014
• 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