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

Catalog Number	552102
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although the device involved is 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: during the course of labor and in anticipation of a delivery, an epidural was placed in the patient's back.The patient delivered a full-term baby at (b)(6) on (b)(6) 2017.Patient was discharged home on (b)(6) 2017.On (b)(6) 2017, patient began running a fever and experiencing pain in her leg.The pain continued to increase and radiated down her legs and into her hips and back to the point that, by (b)(6) she was shaking and could not walk.On (b)(6) 2017, the patient underwent surgery due to a ruptured abscess in her spine caused by the contaminated epidural instrumentation used on (b)(6) 2017.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.The sterility report for this finished good lot was evaluated, and no deviations or abnormalities were found.  review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.A review of the batch history records was also performed and no non-conformances or deviations were noted.  if additional pertinent information becomes available a follow-up report will be filed.

• 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: 9115447
• Report Number: 2523676-2019-00171
• Device Sequence Number: 16718939
• Product Code: OGE
• UDI-Device Identifier: 04046964843846
• UDI-Public: 04046964843846
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 11/30/2018
• Device Catalogue Number: 552102
• Device Lot Number: 0061551535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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: Required Intervention