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

Model Number 332128

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2020

Event Type  malfunction  

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 Description

As reported by the user facility: customer reports: tip of 20 ga catheter missing when removed.Detailed inquiry description: when catheter removed from patient, blue tip was missing.Used as continuous pnb for femoral block.Clinician experienced mild to moderate resistance when removing catheter, but it did not stretch or break.When catheter came out, noticed blue tip was not present.Patient was x-rayed and radiologist report stated "no foreign body" but as doc mentioned, they were not looking for that.They do see something in the area that looks like the size of the tip, but not certain.No further treatment is planned, patient was notified, and discharged.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Based on the data from the investigation we are unable to determine the root cause of the reported incident.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
• Type of Device: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9800826
• MDR Text Key: 182938930
• Report Number: 2523676-2020-00068
• Device Sequence Number: 1
• Product Code: OGJ
• UDI-Device Identifier: 04046964177583
• UDI-Public: 04046964177583
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 332128
• Device Catalogue Number: 332128
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR