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

Model Number	332292
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and 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: there was resistance met when threading the catheter.Upon removal of the catheter, it was noted that the tip was missing.No additional information provided.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although no samples were returned, two pictures were supplied by the manufacturer.The returned pictures were visually evaluated per specification.No defects were able to be identified from the returned pictures.As a reminder, 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.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
• MDR Report Key: 9731956
• Report Number: 2523676-2020-00025
• Device Sequence Number: 362049
• Product Code: OGE
• UDI-Device Identifier: 04046964179044
• UDI-Public: 04046964179044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 07/31/2020
• Device Model Number: 332292
• Device Catalogue Number: 332292
• Device Lot Number: 0061670337
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1