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)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used catheter without packaging was returned for evaluation.Visual examination of the catheter noted no visual defects and passed functional, leakage and occlusion testing per specification.The returned catheter functioned as intended per specification.Based on the results of the sample evaluation, the product met internal specifications.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.
Event or Problem Description
As reported by the user facility: patient was in for induced labor, c-section.Two attempts at epidural catheter placement resulted in subarachnoid placement of catheter - catheter migrated "inter-thecally".Body position, sitting upright level l2-l3; sab local anesthetic 1.6 ml.Epidural replaced level l3-l4.During the labor epidural progress, the iv was not functioning, ephedrine 35mg im given, iv was restarted, neo 200mcb iv given, 15 mg ephedrine iv given.Re-dose - bupivacaine 0.5cc.25%, patient was comfortable after re-dose and baby was delivered successfully.Catheter was left in place and removed next morning, tip was intact.Patient had blood patch due to suspected spinal headache.No further information could be provided.

• 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: 7426598
• Report Number: 2523676-2018-00027
• Device Sequence Number: 16551650
• 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): 04/12/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/12/2018
• 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: 22 YR
• Patient Weight: 84