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

Catalog Number	332079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: our issue is that the catheter is separating at a point in the intro to the patient where it can cause harm, so this is not about the lack of connectivity, it is about a physical defect where the catheter has broken twice where we were trying to introduce anesthesia into a patient.No injury reported.
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.Note: the customer indicates the defect occurs "twice".This is to capture the 2nd event where no additional information was provided.1st event reported under mdr # 2523676-2024-00243 (b.Braun medical internal report number (b)(4)).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used catheter with lidstock packaging was returned for evaluation.Visual inspection of the just catheter show the no damage, shearing or breakage.See photo.The catheter was attached to a connector and tested for occlusion per specification with passing results.The returned product was visually and functionally tested and the reported defect was not confirmed.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.During a follow up it was mentioned that the patient had pain as a result of the breakage.Section h6 clinical code e was updated.

• 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: 18828256
• Report Number: 2523676-2024-00244
• Device Sequence Number: 14214940
• Product Code: OGE
• UDI-Device Identifier: 04046964177224
• UDI-Public: (01)04046964177224
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2024

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: 04/30/2025
• Device Catalogue Number: 332079
• Device Lot Number: 0061913646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 11/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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