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

Model Number	332078
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)
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: it was reported that clinician was unable to thread epidural catheter beyond needle tip during procedure.After removing and performing procedure with additional device, suspected defective equipment taken to anesthesia work room for evaluation.Adherent fragment of the interior needle broke free after multiple mechanical advancements.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400479341.No photos or videos were provided for evaluation.Based on the data from our evaluation, the exact root cause of the reported defect could not be determined at this time.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.

• Brand Name: PERIFIX
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10385412
• Report Number: 2523676-2020-00204
• Device Sequence Number: 19750272
• Product Code: OGE
• UDI-Device Identifier: 04046964177200
• UDI-Public: 04046964177200
• Combination Product (Y/N): N
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 06/01/2021
• Device Model Number: 332078
• Device Catalogue Number: 332078
• Device Lot Number: 0061729497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1