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

Catalog Number	552006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although it was confirmed that the device involved in not available for evaluation, 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: customer reports, potential epidural catheter shearing.Crna was performing a standard epidural placement.Catheter was placed as usual.Crna tried to reposition the catheter and encountered resistance.Upon being unable to manipulate the catheter the catheter and needle were removed.Once removed the crna noted that the tip of the catheter was missing and inner wire of the catheter was exposed.The catheter's inner wire coil was intact but the tip of the catheter was missing about 2cm of the soft polyamide.Catheter was removed and a second catheter was placed.Patient was discharged.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was received for evaluation.Without the actual device, a thorough investigation could not be performed.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.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or 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: 8267650
• Report Number: 2523676-2018-00123
• Device Sequence Number: 14046037
• Product Code: OGE
• UDI-Device Identifier: 04046964311215
• UDI-Public: 04046964311215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 11/30/2019
• Device Catalogue Number: 552006
• Device Lot Number: 0061623951
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/21/2019
• 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: Other
• Patient Age: 39 YR