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

Catalog Number	333514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The reported defect was unable to be confirmed.The actual defective device is valuable tool in investigating the cause of this incident.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.
Event or Problem Description
Per medwatch number (b)(4): describe event or problem: the catheter sheared while being removed from the patient.The wire coil separated from the plastic sheath.A portion of the plastic sheath appears to have remained inside the patient.The plastic sheath was unable to be located on ct or mri.The manufacturer has informed us that the plastic sheath is radio translucent, while the wire coil is radiopaque.This is likely why we were unable to visualize the plastic sheath with imaging (the wire coil separated from the plastic sheath, so the wire coil was fully removed from the patient).The product safety concern in this case is that the plastic sheath is not radiopaque.Making the plastic sheath radiopaque would allow for it to be located in situations such as these.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used catheter without packaging was provided for evaluation.Upon visual inspection of the returned sample, it was observed to be sheared, damaged, and the coil was pulled/ stretched out of the catheter.Based on the data from the investigation, the reported defect was unable to be confirmed to be a manufacturing defect.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.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: 22131706
• Report Number: 2521402-2025-00056
• Device Sequence Number: 8353916
• Product Code: OGE
• UDI-Device Identifier: 04046964179907
• UDI-Public: (01)04046964179907
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/16/2025

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 Catalogue Number: 333514
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White