MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG COMBINED SPINAL & EPIDURAL; EPIDURAL ANESTHESIA KIT

Model Number	4556763
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number: (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Device history record (dhr): reviewed the dhr and no abnormality was observed during in-process inspection.Sample evaluation: no sample were returned for evaluation; however, we received 2 customer pictures of a complained espocan + ds+pst+penc 0.42x138, 5mm 27g.Investigation results: the first customer picture shows the package with the variable data.The second customer picture shows the closed soft tip catheter 20g non-sterile with a comparison/reference sample.At the used catheter the part with the catheter tip is cut off.The cut off part is not shown.The damaged area at the catheter is slanted and is due to the retraction of the catheter in the cannula.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Recommendation from instruction for use: never pull the catheter through the needle as it may otherwise shear off.Conclusion: upon inspection based on the received picture, no mechanical damages or manufacturing faults were observed.Therefore, we assume a fault during the application process.The complaint is not confirmed.
Event or Problem Description
According to the event description: "catheter broke down in patient body.".

• Brand Name: COMBINED SPINAL & EPIDURAL
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21549633
• Report Number: 9610825-2025-00081
• Device Sequence Number: 4420159
• Product Code: OGE
• UDI-Device Identifier: 04046964940613
• UDI-Public: (01)04046964940613(11)230615(17)280601(10)23F15G8F02
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: 4556763
• Device Lot Number: 23F15G8F02
• 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: 02/08/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: Unknown