MAUDE Adverse Event Report: PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	332097
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2021
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: per medwatch form mw5102773: "epidural catheter placed for pain management for labor (b)(6) 2021.Upon removal, the catheter was fractured with 2 cm of the catheter remaining in the patient's spine.Neuro surgeon consulted and recommended for retained catheter fragment to remain.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used catheter connector, catheter and filter, without packaging was provided for evaluation.Visual evaluation of the catheter showed the end of the catheter to be severely, bent, kinked, frayed and sheared off.Since the catheter had been used, the damage and breakage is not confirmed to be the result of any manufacturing process, rather due to the user`s application.User should refer to ifu which states, "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." review of the discrepancy management system (dsms) database 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.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• MDR Report Key: 12364284
• Report Number: 2523676-2021-00281
• Device Sequence Number: 17128193
• Product Code: OGE
• UDI-Device Identifier: 04046964177361
• UDI-Public: 04046964177361
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2021

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: 03/01/2022
• Device Model Number: 332097
• Device Catalogue Number: 332097
• Device Lot Number: 0061782465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2021
• 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