MAUDE Adverse Event Report: BD; ANESTHESIA CONDUCTION KIT

Model Number	405828
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11790115
• Report Number: MW5101234
• Device Sequence Number: 4635119
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: (01)00382904058289
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 405828
• Device Lot Number: 001393406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): No Information
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1