MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	332220
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: customer reported that during a birth (possibly a c-section), the catheter in the continuous epidural tray was knotted during insertion into the patient but was not obvious at administration (was not noted prior to placement).As the medical staff could not remove the tuohy needle nor were they able to inject through the catheter, they removed the catheter and the needle together and noticed a knot in the catheter.The staff grabbed another product from the exact same tray, and it worked fine.To the reporter's knowledge there were no complications that occurred during the procedure due to the reported device malfunction nor was any medical intervention required.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample was returned for evaluation.Visual evaluation of the sample showed the used catheter to be stretched and knotted.Since the customer stated the catheter was not damaged or knotted before insertion and it had been used for the procedure, the reported failure could not be confirmed to be related to any manufacturing process but caused by application error.The user will be referred to the ifu (instructions for use).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: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA 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: 15633907
• Report Number: 2523676-2022-00517
• Device Sequence Number: 12747948
• Product Code: OGE
• UDI-Device Identifier: 04046964178320
• UDI-Public: (01)04046964178320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 09/30/2023
• Device Model Number: 332220
• Device Catalogue Number: 332220
• Device Lot Number: 0061836413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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