MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX; NERVE BLOCK TRAY (KIT)

Model Number	331641
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/03/2020
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.
Event or Problem Description
As reported by the user facility: description of issue: on (b)(6) 2020, patient received a femoral nerve block.On (b)(6) 2020, the catheter was removed and 1 cm of the blue tip was noted to be missing.It appeared that the tip was sheared off.An x-ray was done and no catheter was seen.No redness, tenderness, swelling was noted at the site.Surgeon was consulted and it was recommended to monitor the site.No additional treatments were performed.
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 evaluation of the sample showed the catheter to be torn/sheared near the tip.Based on the evaluation results, this type of defect could have happen during application.User should refer to ifu which states, "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." 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.

• Brand Name: CONTIPLEX
• Common Device Name: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9720667
• Report Number: 2523676-2020-00012
• Device Sequence Number: 16732480
• Product Code: OGJ
• UDI-Device Identifier: 04046964991547
• UDI-Public: 04046964991547
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 331641
• Device Catalogue Number: 331641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR