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

Catalog Number	332200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
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: detailed inquiry description: on monday (b)(6) 2025 a patient had an epidural catheter placed intraoperatively for pain control following a multi-level posterior spinal fusion.On pod 2 when the pa was revving the catheter, it separated, and a section of the catheter remained in the patient's back.The patient returned to the or later that afternoon for an exploration of the post-op lumbar wound and removal of the retained epidural catheter.The segment was successfully removed.Both the anesthesiologist & the surgeon feel that the catheter was defective.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A total of three (3) catheters (one used catheter, one partial catheter taped to a paper, and one partial catheter in a container) were provided for evaluation.Visual evaluation of the samples showed the two of the three catheters to be sheared off.Although two catheters were observed to be sheared, it was not confirmed to be the results of any manufacturing process.B braun kits are packaged according to blueprint specifications while inspecting for any defects or deviations from drawing (e.G.Embedded particles, dirt, missing or incorrectly assembled parts, etc.).In addition, there are incoming, in process and final functional inspections performed during the manufacturing of components and finished good items.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.The most likely root cause is due to further processing/handling during clinical 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.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22814797
• Report Number: 2521402-2025-00419
• Device Sequence Number: 8666381
• Product Code: OGE
• UDI-Device Identifier: 04046964178061
• UDI-Public: 04046964178061
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 332200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 103 KG