MAUDE Adverse Event Report: BARD ACCESS PICC SOLO CATHETER W/SHERLOCK 3CG; POSITIONING SYSTEM STYLET

Catalog Number 1295108FD

Device Problems Kinked (1339); Defective Device (2588)

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

Event Date 09/18/2017

Event Type  Injury  

Event Description

Device was found to be physically defective upon removal from the package.Area of a noticeable damage (kinked) is approximately 5cm from the distal end.Item was not used and a new package opened.

• Brand Name: PICC SOLO CATHETER W/SHERLOCK 3CG
• Type of Device: POSITIONING SYSTEM STYLET
• Manufacturer (Section D): BARD ACCESS; salt lake city UT 84115
• MDR Report Key: 6914002
• MDR Text Key: 88269713
• Report Number: MW5072598
• Device Sequence Number: 1
• Product Code: OBJ
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1295108FD
• Device Lot Number: REBU0056
• 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?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 71