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

Catalog Number 331758

Device Problem Break (1069)

Patient Problems Neuropathy (1983); Foreign Body In Patient (2687)

Event Date 04/10/2019

Event Type  malfunction  

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 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®
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 9220505
• MDR Text Key: 177962180
• Report Number: 2523676-2019-00180
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04046964177088
• UDI-Public: 04046964177088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 331758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• 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