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

Model Number	332220
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
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: perifix epidural kit used.Patient consented for labor epidural.Positioned sitting, loss of resistance technique with syringe provided in kit.Saline drawn up into lor syringe, attached to epidural needles, initially working appropriately, epidural needle advanced with continuous pressure.Resistance to advancement noted at likely ligamentum flavum.Attempted lor negative.Advanced slightly, negative lor.Syringe removed and returned of free flow of clear fluid seen from epidural needle (likely csf).Syringe replaced, still no ability to inject saline.Epidural removed.Syringe inspected and found to have become seized up where plunge contacts side of glass syringe.Unable to either withdraw or advance plunger.Patient informed of dural puncture, and procedure repeated using a different epidural tray without difficult.Will likely result in pdph and need for therapeutic epidural blood patch.Patient's medical condition: epidural for labor.Extent of injury: dural puncture, b.Nature of intervention: epidural blood patch.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used syringe without packaging was returned for evaluation.Visual evaluation of the syringe did confirm the plunger to be stuck in the barrel that was filled with an unknown residual fluid.The plunger could not be moved at all, and the glass appeared to be clouded, also with the residual fluid.Visual evaluation of the returned sample confirmed the reported defect.Although the defect was confirmed, the exact root cause of the crack was not able to be determined at this time.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.Additionally, a historical review of the customer complaint database dating back one year revealed no other complaints of this nature against this finished good item or lot number.Therefore, this is considered to be an isolated incident and no formal corrective action is warranted at this time.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: 16582512
• Report Number: 2523676-2023-00071
• Device Sequence Number: 17317003
• Product Code: OGE
• UDI-Device Identifier: 04046964178320
• UDI-Public: (01)04046964178320
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/28/2023

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: 05/31/2024
• Device Model Number: 332220
• Device Catalogue Number: 332220
• Device Lot Number: 0061864509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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: 26 YR
• Patient Sex: Female
• Patient Weight: 71 KG