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

Catalog Number	333521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2025
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: catheter tip broke off at end of tuohy needle when used for peripheral block.Foreign matter remains in patient.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used catheter was provided for evaluation.Upon receipt of the sample, visual evaluation was conducted and it was observed that the catheter tip was stretched; however, no breakage was identified.Based on the investigation finding, the reported defect of catheter breakage was not confirmed.Braun kits are packaged according to blueprint specifications, with inspection for any defects or deviations from the design drawings (e.G., embedded particles, dirt, missing or incorrectly assembled components, etc.).In addition, incoming, in-process, and final functional inspections are performed throughout the manufacturing of both components and finished good items.Based on the manufacturer's investigation, the reported defect is not likely to have occurred during the manufacturing process.Instead, available evidence indicates that the issue most likely occurred during application, specifically during removal of the catheter.Users should refer to the instructions for use (ifu), which states: "warnings: · do not apply excessive force during needle advancement.Do not utilize the needle if it bends or the tip becomes damaged.A needle with a damaged tip increases the risk of intrathecal or intravascular placement.· if resistance is felt during advancement of the needle, carefully correct the orientation of the needle, but never apply excessive force.Following puncture and verification of the epidural space, introduce the catheter tip through the epidural needle using the thread assist guide.Caution: do not withdraw the catheter through the needle because of the possible danger of shearing or kinking.Insert the catheter to the desired depth.Precaution: advancing the catheter more than 5 cm past the needle tip may increase the likelihood of kinking or knotting.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." a review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 24267575
• Report Number: 2521402-2026-00099
• Device Sequence Number: 10722922
• Product Code: OGE
• UDI-Device Identifier: 04046964179945
• UDI-Public: (01)04046964179945(11)230424(17)260331(10)0061879471
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 03/31/2026
• Device Catalogue Number: 333521
• Device Lot Number: 0061879471
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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