MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS; EPIDURAL ANESTHESIA KIT

Model Number	552030
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).To date it is unknown if the device involved will be available evaluation, the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
Per medwatch number (b)(4): anesthesiologist was placing the epidural for the patient at bedside when the epidural catheter broke, leaving 5.5-6 cm of the catheter in the patient's epidural space.Anesthesiologist covered the insertion site with a gauze.He consulted with other anesthesiologist and neurosurgery.A spinal block was performed.Patient was advised that neurosurgery would be consulting her during her hospital stay.Patient remained stable.Lower lumber x-ray was taken.Epidural catheter was not visualized.After evaluation by neurosurgery, no intervention recommended at this time.The patient will followed up later this month to discuss necessity of a ct scan for actual visualization.Neurosurgery only recommends this should she wish to proceed with having it removed.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for further evaluation.Without the actual device, a thorough investigation could not be performed.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.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: DESIGN OPTIONS
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9694004
• Report Number: 2523676-2020-00038
• Device Sequence Number: 1742530
• Product Code: OGE
• UDI-Device Identifier: 04046964312106
• UDI-Public: 04046964312106
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 02/28/2021
• Device Model Number: 552030
• Device Catalogue Number: 552030
• Device Lot Number: 0061690042
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1