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

Catalog Number	552079
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880); Respiratory Distress (2045); Loss of consciousness (2418)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).As reported by the user facility, it was confirmed that the sample was not saved, the sample was discarded.Without the actual device, a thorough investigation could not be performed.Review of the discrepancy management system database was unable to be performed because the lot number was reported as unknown.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.
Event or Problem Description
As reported by the user facility: during preparation to perform a c-section - epidural bolused with 8 ml 2% lidocaine initially.Patient rapidly developed difficulty breathing and lost consciousness immediate respiratory arrest, requiring bvm vent and emergent intubation on the unit.Patient was taken to or for c-section with general anesthesia, ultimately extubated and taken to pacu.Baby did well.Epidural catheter migrated intra-thecally resulting in a high spinal, confirmed by lab evaluation of aspirate.Patient experienced complications of extremity paresthesia, seen by neurologist while in hospital and is expected to resolve # l4-5 nerve irritation/radiculopathy; urinary retention - went home with a catheter to be removed in a couple of days; and positional headaches." anesthesiologist denies saddle distribution of anesthesia.Confirmed a blood patch was completed 4 days after the procedure.To date, no further complications to patient has been reported.

• 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: 7419050
• Report Number: 2523676-2018-00026
• Device Sequence Number: 806292
• Product Code: OGE
• UDI-Device Identifier: 04046964675607
• UDI-Public: 04046964675607
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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 Catalogue Number: 552079
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/10/2018
• 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
• Patient Age: 25 YR
• Patient Weight: 78