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

Model Number	331693
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).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: it was reported that the distal tip broke off inside patient.Detailed inquiry description.The dr.Performed an adductor block and successfully placed contiplex tuohy/catheter 331693 system.A few days post sx, the catheter became dislodged, however, the distal tip of the catheter remained in the patient.The patient was not in any pain.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was provided for evaluation.Visual evaluation of the catheter showed the catheter was used, contaminated, and damage.Since the catheter had been used, the damage and breakage is not confirmed to be the result of any manufacturing process, rather due to the user`s application.The user will be referred to the ifu which states, "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." 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
• 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: 12530987
• Report Number: 2523676-2021-00325
• Device Sequence Number: 17127969
• Product Code: CAZ
• UDI-Device Identifier: 04022495769497
• UDI-Public: (01)04022495769497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 331693
• Device Catalogue Number: 331693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/26/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown