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	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).  no sample and/or lot number was provided for further evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed.  we will maintain this report for further references and continue to monitor other reports for similar occurrences.  if any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: it was reported that upon removal of the periflex epidural catheter, there was approximately 1cm of catheter tip retained.No injury 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: 10603353
• Report Number: 2523676-2020-00281
• Device Sequence Number: 3054182
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR