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

Catalog Number	333196
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2024
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: physician reported multiple problems with above-mentioned product clamp0 not closing properly, difficulty with medication delivery-difficult to push, and claim not functioning properly resulting in retained object.Unfortunately lot numbers were not captured as product was discarded.Vpco reeducated on savings products to root cause and appropriately report.Physician advised will uptrain team on appropriate handling of failed products to capture lot number to root cause.Issues started in june 2024 with difficulty in pushing medication.Dr.Hassan iqbal contacted vendor to report and vendor revamped kit with resolution.No repeat occurrences reported until approximately october when several end-users reported difficulty with pushing medication.Dr.Iqbal personally led case and replicated difficulty with pushing medications.On a separate case on 12/17/24, morbidly obese patient used same epidural tray and catheter shredded and retained body left in patient.Reported to supply chain and vendor contacted.Vendor offered to replace catheters.Supply chain director reported to vp clinical operations.Vp advised patient safety officer and entered product quality form, shared with warehouse and started investigation with physician end-user.Number of occurrences are at least five.Desired outcome is investigation and full credit.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample was provided for evaluation.Upon visual inspection of the returned sample, it was observed to be severly damaged.The coil was frayed and the tip was sheared off.The coil of the catheter was unable to be measured or tested for occlusion.Based on the data from the investigation, the reported defect was unable to be confirmed to be the result of any manufacturing process.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.An approved project is in place to further address issues with the coil being out of specification, causing kinking and occlusion of catheters.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 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: 21091937
• Report Number: 2523676-2024-01194
• Device Sequence Number: 15641476
• Product Code: OFT
• UDI-Device Identifier: 04046955899531
• UDI-Public: (01)04046955899531
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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 Catalogue Number: 333196
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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