MAUDE Adverse Event Report: CONTIPLEX®; ANESTHESIA CONDUCTION KIT

Model Number 332170

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: it was reported that the catheter was unable to be removed from the patient after being in place for several days.The catheter was a femoral nerve catheter and required a surgical procedure to have the catheter removed.Patient injury - surgical procedure required to remove catheter.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Two (2) photos were provided by the reporting facility.Visual evaluation of the photos showed a used catheter that was twisted/knotted and damaged.However, the photos did not definitively confirm any visual manufacturing defect on the catheter.Visual evaluation of the photos could not confirm any manufacturing defect on the used catheter.The house retain samples of the reported lot were visually inspected per specification with passing results.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.In addition, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.Per the evaluation and investigation of the retain samples and device history records (dhr for both involved lots of catheters, this defect is not likely to have happened during the manufacturing process.User should refer to ifu which states, "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." we will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: CONTIPLEX®
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10295624
• MDR Text Key: 199494732
• Report Number: 2523676-2020-00198
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04046955150663
• UDI-Public: 04046955150663
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 332170
• Device Catalogue Number: 332170
• Device Lot Number: 0061698024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention