MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD; ANESTHESIA CONDUCTION KIT

Model Number 405828

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Bd combined epidural spinal kit 405828, lot 0001393406 has had repeated epidural catheter failures.Catheter breaks excessively easily.None have broken within a patient.All have broken prior to the tape being removed and the catheter being removed.Fda safety report id# (b)(4).

• Brand Name: BD
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; franklin lakes NJ
• MDR Report Key: 11790115
• MDR Text Key: 249801732
• Report Number: MW5101234
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: (01)00382904058289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 405828
• Device Lot Number: 001393406
• Was Device Available for Evaluation?: No
• 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