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	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.
Event or Problem Description
According to medwatch user facility report (b)(4): during insertion of the epidural catheter through the needle, the catheter did not thread past 12 cm.Attempts to withdraw the catheter back were futile as the catheter remained stuck at approximately 10 cm.During one such attempt, the catheter snapped and the entire catheter with the wire came out except for the blue tip at the end.Epidural was resited with a different set and patient had a good outcome for labor and delivery.The possibility of a catheter fragment left behind was immediately disclosed to the patient.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).This supplement is being sent to add the medwatch number, (b)(4), to section h10.A follow-up report will be provided after the examination results are available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample or lot was provided for evaluation.We are unable to determine the root cause of the reported incident.The reported defect was unable to be 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.

• 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: 19392433
• Report Number: 2523676-2024-00541
• Device Sequence Number: 18083142
• Product Code: OGE
• UDI-Device Identifier: 04046964177224
• UDI-Public: 04046964177224
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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 Catalogue Number: 332079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 05/29/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Weight: 88 KG
• Patient Race: Black Or African American