MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX; NERVE BLOCK TRAY (KIT)

Catalog Number	332143
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample and/or lot number.Without the actual device, a thorough investigation could not be performed.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: complaint: anesthesiologist stated that approximately 3 cm of a polyamide catheter tip remained in patient after placement of a continuous peripheral nerve block (adductor block).Anesthesiologist stated she felt some resistance during placement of needle and catheter.It felt like the catheter was "stuck in the needle" and upon removal of the needle and catheter, it was noted that the tip of the catheter had "sheared" off.Anesthesiologist was concerned about the broken tip that remained in the patient as the patient was currently in the operating room for surgery.No recommendation was given.Customer was provided with type of catheter - polyamide and informed the catheter is biocompatible.Injury - broken tip of catheter remained in patient.

• Brand Name: CONTIPLEX
• Common Device Name: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7953688
• Report Number: 2523676-2018-00080
• Device Sequence Number: 11182857
• Product Code: OGJ
• UDI-Device Identifier: 04046964991509
• UDI-Public: 04046964991509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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 Expiration Date: 09/30/2019
• Device Catalogue Number: 332143
• Device Lot Number: 0061599649
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR