MAUDE Adverse Event Report: CR BARD, INC. BARD CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM

Lot Number RECQ0432

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/25/2018

Event Type  Injury  

Event Description

Power picc catheter solo 2 ft with sherlock 3cg was placed into the cephalic vein without any resistance or problem.X-ray was taken to confirm placement and a metallic device was seen upon x-ray.Apparently, a portion of the wire was left behind in the pulmonary vein when the wire was retracted out.This had to be retrieved by an interventional radiologist which were able to retrieve the retained wire.Dates of use: (b)(6) 2018.Diagnosis or reason for use: picc line to be used for medication administration.

• Brand Name: BARD CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM
• Manufacturer (Section D): CR BARD, INC.
• MDR Report Key: 7565007
• MDR Text Key: 110162555
• Report Number: MW5077606
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Lot Number: RECQ0432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 91