MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. 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	12/05/2019
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.Please note: this report is being resubmitted.The mfr report number (2523676-0190-00240) that was originally submitted on 13-jan- 2020 was incorrect.The correct mfr report number is 2523676-2019-00240.
Event or Problem Description
Per medwatch number mw5091658.It was reported that the epidural catheter broke, leaving 12cm of epidural catheter in patient.No injury reported.Please note: this report is being resubmitted.The mfr report number (2523676-0190-00240) that was originally submitted on 13-jan- 2020 was incorrect.The correct mfr report number is 2523676-2019-00240.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Further investigation of the complaint is not possible without a sample and/or lot number.If a sample and/or any additional pertinent information becomes available the complaint will be re-opened and a thorough investigation will be performed.We will maintain this report for further references and continue to monitor other reports or similar occurrences.The batch record and our discrepancy management system database could not be reviewed as a lot number was not 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: 9699558
• Report Number: 2523676-2019-00240
• Device Sequence Number: 2857847
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR