MAUDE Adverse Event Report: DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT

Model Number	551731
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.It should be noted that potential lot numbers were provided, as follows: lot 0061747995: production date: 09/21/2020; expiration date: 09/30/2021.Lot 0061732989: production date: 07/20/2020; expiration date: 06/01/2021.This event was reported to the fda under medwatch # 5098813.
Event or Problem Description
As reported by the user facility: "upon removal of the perifix epidural catheter, a portion of the catheter tip was retained within the patient.The retained portion was left in place.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400501419.No sample was provided for evaluation.Further investigation of the complaint is not possible.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
• MDR Report Key: 11302045
• Report Number: 2523676-2021-00017
• Device Sequence Number: 11969628
• Product Code: OGE
• UDI-Device Identifier: 04046964307867
• UDI-Public: 04046964307867
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/29/2021

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: 551731
• Device Catalogue Number: 551731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR