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

Catalog Number 1295108FD

Device Problems Material Discolored (1170); Fracture (1260); Kinked (1339)

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

Event Date 07/24/2017

Event Type  Injury  

Event Description

Upon removal of the guide wire and sizing of the catheter length, it was noticed that the wire tip was discolored and the tip was kinked.After touching the bend the tip fractured.New product was used to proceed with the case.

• 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: 6773423
• MDR Text Key: 82154358
• Report Number: MW5071430
• 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: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1295108FD
• Device Lot Number: REBT0756
• 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: 36 YR
• Patient Weight: 198