MAUDE Adverse Event Report: CONTIPLEX®; ANESTHESIA CONDUCTION KIT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (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: event 3: per conversation, three (3) occurrences of contiplex echo catheter breakage.For two (2) of the occurrences, the catheter needed to be removed surgically.For the third occurrence, the catheter was removed at the bedside.The breakages occurred during insertion or were noted at the time of removal.

Manufacturer Narrative

This report has been identified as event 3 of b.Braun medical internal report number (b)(4).Two (2) photos were provided for evaluation.The two photos depicted a used catheter that had been broken toward the tip.When investigated further, it was determined that this breakage could not have been due to any manufacturing problem, and thatt the damage is due to improper application technique.Review of the discrepancy management system (dsms) database and a review of the batch history records was unable to be performed, as no lot number was provided.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: CONTIPLEX®
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10592458
• MDR Text Key: 208749234
• Report Number: 2523676-2020-00274
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 22 YR