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

Model Number	4556763
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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.
Event or Problem Description
According event description: catheter snapped during insertion of epidural catheter procedure.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical 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.Investigation statement: we received one used accu-bloc-kath.20g, einz.Unst."s-o"soft-t out of one espocan + ds+pst+penc 0.42x138,5mm 27g in open packaging.At the used accu bloc catheter the part with the catheter tip is cut off the cut off area shows a smooth structure.The cut off part was not handed over by the customer.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is slanted and is due to the retraction of the catheter in the cannula.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.The catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.Because of this we assume of a problem during the application process.Recommendation never pull the catheter through the needle as it may otherwise shear off.Therefore, the complaint is not confirmed.

• 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: 21170736
• Report Number: 9610825-2024-01031
• Device Sequence Number: 17212467
• Product Code: OGE
• UDI-Device Identifier: 04046964940613
• UDI-Public: (01)04046964940613(11)240405(17)290401(10)24D05G8F05
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 24D05G8F05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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: 33 YR
• Patient Sex: Female