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

Catalog Number	332097
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	09/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description: broken fx catheter in patient detailed inquiry description: l&d patient has part of fx catheter that has sheared off in back.One of the physicians was having difficulty advancing the catheter into the epidural space so the needle and the catheter were both removed with the intent of re-directing.Upon removal, the end of the catheter was missing, and the wire was uncoiled.A new epidural catheter had to be placed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One photo was provided by the reporting facility.Visual evaluation of the photo showed a used catheter that was sheared off and the spring to be exposed at the section that was sheared.Although the photo did show the catheter to be sheared/broken, the provided picture does not offer any details necessary to confirm the reported defect was related to any manufacturing process.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.User will be referred to the ifu which states, precaution: advancing the catheter more than 5 cm past the needle tip may increase the likelihood of kinking or knotting.Caution: do not withdraw catheter 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." 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: 17895916
• Report Number: 2523676-2023-00602
• Device Sequence Number: 6998362
• Product Code: OGE
• UDI-Device Identifier: 04046964177361
• UDI-Public: (01)04046964177361
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2023

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: 332097
• 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: 09/26/2023
• Initial Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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