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

Model Number	333192
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: crna inserted an epidural catheter for patient's vaginal delivery.When removing the catheter, nurse observed that the tip of the catheter was missing, and the end was irregular.Nurse that removed catheter indicated there was no resistance during removal.The b.Braun catheter was compared to others, and it was determined to be 2.25 inches shorter than the other unused catheters.The patient was x-rayed, and nothing was found.Patient was not symptomatic.Patient was discharged the next day.The ob provider reached out to a neurosurgeon.The neurosurgeon recommended additional radiological views (4 cervical views; sacral, l-s, ap lateral view) of the patient.The patient had additional xrays of her thoracic spine, skull, cervical spine and sacrum/coccyx area and no foreign body was found.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.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 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16711972
• Report Number: 2523676-2023-00079
• Device Sequence Number: 1614488
• Product Code: OGE
• UDI-Device Identifier: 04046964179266
• UDI-Public: (01)04046964179266
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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 Expiration Date: 04/30/2024
• Device Model Number: 333192
• Device Catalogue Number: 333192
• Device Lot Number: 0061850779
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Race: White