MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX®; ANESTHESIA CONDUCTION KIT

Catalog Number	331758
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Neuropathy (1983); Foreign Body In Patient (2687)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number was provided for further evaluation.Further evaluation of the complaint is not possible.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: patient called to report that he sustained a retained nerve block catheter during a procedure that was performed on (b)(4) 2019.Per the patient, he was informed by the surgical team that after removal it was noted that the catheter tip had broken off, and the "black tip" was missing.There were no interventions performed to the patient at the time of the event.But now the patient is complaining of neurotpathies to the lower leg.

• Brand Name: CONTIPLEX®
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9220505
• Report Number: 2523676-2019-00180
• Device Sequence Number: 13999046
• Product Code: CAZ
• UDI-Device Identifier: 04046964177088
• UDI-Public: 04046964177088
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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 Catalogue Number: 331758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1