MAUDE Adverse Event Report: CONTIPLEX®; ANESTHESIA CONDUCTION KIT

Model Number	332170
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported by the user facility: event 3: end user reports that the catheter is shearing during use.No injury reported.
Additional 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®
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10323026
• Report Number: 2523676-2020-00213
• Device Sequence Number: 19770449
• Product Code: CAZ
• UDI-Device Identifier: 04046955150663
• UDI-Public: 04046955150663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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 Model Number: 332170
• Device Catalogue Number: 332170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/26/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1