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

Model Number	333196
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2020
Type of Reportable Event	Serious Injury
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: wire from fx springwound catheter was left in patient's back.Details of report: patient had first epidural placed unsuccessfully (not a b.Braun product) tried this device for 2nd attempt, also unsuccessful.Used a 3rd kit (not a b.Braun product) to successfully place epidural.When placing catheter on second attempt resistance was met, "felt like a burr".Removed needle and catheter together, but part of catheter remained, noted metal in skin.Patient was transferred to another facility to have ct scan of are due to paresthesia of the skin from rib cage down most pronounced to legs front and back.Ct revealed a metal wire fragment.Surgery to remove fragment revealed approximately 10 cm of catheter from patient.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No photos or videos were provided for evaluation.Retained units for the reported batch number were visually examined, and no shearing, burrs, or damage of any kind was noted.Based on the data from our evaluation, the exact root cause could not be determined at this time.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformance's noted during in process or final product inspection.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
• MDR Report Key: 10406461
• Report Number: 2523676-2020-00232
• Device Sequence Number: 14203482
• Product Code: OFT
• UDI-Device Identifier: 04046964179303
• UDI-Public: 04046964179303
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 333196
• Device Catalogue Number: 333196
• Device Lot Number: 0061722575
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2020
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention