MAUDE Adverse Event Report: PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	332095
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
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: fx epidural catheter possible shearing.On june 5th, the doctor believes he had catheter shearing, but nothing was found on scan of patient.During the procedure, the doctor felt no resistance, so he removed the catheter.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation, however a picture was provided.Visual evaluation of the picture showed a used, stretched catheter without packaging.Although the used sample appeared stretched and damaged, it does not appear to be the result of any manufacturing/packaging process.A 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.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation, however a picture was provided.Visual evaluation of the picture showed a used, stretched catheter without packaging.Although the used sample appeared stretched and damaged, it does not appear to be the result of any manufacturing/packaging process.A 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.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.Correction: h6: investigation findings code was missed on previous follow-up report.This code has been entered on this report.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• MDR Report Key: 12018309
• Report Number: 2523676-2021-00181
• Device Sequence Number: 19689445
• Product Code: OGE
• UDI-Device Identifier: 04046964954276
• UDI-Public: 04046964954276
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2021

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: 01/01/2022
• Device Model Number: 332095
• Device Catalogue Number: 332095
• Device Lot Number: 0061771944
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 06/08/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/30/2021; 07/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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
• Patient Age: 34 YR