MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ESPOCAN®; SPINAL EPIDURAL ANESTHESIA

Catalog Number	333192
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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: brief inquiry description - "an epidural cath that broke off into a patient." description of the patient event - "epidural cath broke off into patient." no injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A 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.No sample was returned for evaluation.A representative catheter from of the reported lot number was visually inspected and no damage, defect, or breakage was observed.The reported defect was not confirmed.A possible root cause per the manufacturer's investigation is the defect was not likely to have happened during the manufacturing process.It is believed to happen during application.The user should refer to ifu which states, warnings: · do not apply excessive force during needle advancement.Do not utilize needle if it bends or tip becomes damaged.Needle with damaged tip increases the risk of intrathecal or intravascular placement.· if resistance is felt during advancement of the needle, carefully correct the orientation of the needle but never apply excessive force.Following puncture and verification of the epidural space, introduce catheter tip through epidural needle using the thread assist guide.Caution: do not withdraw catheter through needle because of the possible danger of shearing or kinking.Insert catheter to desired depth.Precaution: advancing the catheter more than 5 cm past the needle tip may increase the likelihood of kinking or knotting.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." 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: ESPOCAN®
• Common Device Name: SPINAL EPIDURAL ANESTHESIA
• 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: 19202175
• Report Number: 2523676-2024-00415
• Device Sequence Number: 8021807
• Product Code: OFT
• UDI-Device Identifier: 04046964179266
• UDI-Public: (01)04046964179266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 05/31/2025
• Device Catalogue Number: 333192
• Device Lot Number: 0061917773
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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