MAUDE Adverse Event Report: CONTIPLEX®; ANESTHESIA CONDUCTION KIT

Model Number 332170

Device Problem Break (1069)

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

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The device involved has been received for evaluation and 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 2: end user reports that the catheter is shearing during use.No injury reported.

Manufacturer Narrative

Event 2: this report has been identified as b.Braun medical internal report number (b)(4).Seven (7) unopened samples were returned for evaluation.The samples were visually inspected and no shearing, damage or any manufacturing defect was able to be observed.In addition physical testing of the catheters was performed to try and replicate/simulate the reported defect.No shearing or breakage was able to be replicated or confirmed.In addition, the house retain samples of the reported lot were visually inspected per specification with passing results.A review of the batch history records was performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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: 10323017
• MDR Text Key: 200468272
• Report Number: 2523676-2020-00212
• 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: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 332170
• Device Catalogue Number: 332170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: No
• 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