MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. ACCUCATH; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number REEY2674

Device Problem Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Event Description

During insertion of an accucath, when the needle was retracted, the wire stylet would not withdraw without removal of the entire catheter.Fda safety report id# (b)(4).

• Brand Name: ACCUCATH
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 11982959
• MDR Text Key: 255987544
• Report Number: MW5101833
• Device Sequence Number: 1
• Product Code: FOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Lot Number: REEY2674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• 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 Age: 28 YR