MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD TRIPLE LUMEN PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number S1385108D

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/26/2021

Event Type  malfunction  

Event Description

Tip of picc guidewire broke off during insertion.Fda safety report id# (b)(4).

• Brand Name: BARD TRIPLE LUMEN PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13652041
• MDR Text Key: 286498287
• Report Number: MW5107801
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: S1385108D
• Device Lot Number: REFP1050
• Patient Sequence Number: 1