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

Model Number	333514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: details of complaint: "catheter pushed in however resistance met.I attempted to pull catheter out, however i began to see the springround coil and not the full surrounding plastic catheter.I believe i then removed both the epidural needle and catheter and found the plastic catheter that remained was missing a little past the 5 cm marking.The inner springround coil seemed to be fully removed.I had to call spine surgery to come in for a consult as now there is potential 5 cm of plastic catheter that remains in her back of unknown location as catheter broke.Patient is pending a lower spine x ray and reassessment by spine surgery.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400563064.No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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: 15189122
• Report Number: 2523676-2022-00387
• Device Sequence Number: 5633573
• Product Code: OGE
• UDI-Device Identifier: 04046964179907
• UDI-Public: (01)04046964179907
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

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 Model Number: 333514
• Device Catalogue Number: 333514
• 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: 07/20/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Race: Asian