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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. CONTIPLEX NERVE BLOCK TRAY (KIT) Back to Search Results
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.

 
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Brand NameCONTIPLEX
Type of DeviceNERVE BLOCK TRAY (KIT)
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, pa 
7197287
MDR Report Key9800826
MDR Text Key182938930
Report Number2523676-2020-00068
Device Sequence Number1
Product Code OGJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number332128
Device Catalogue Number332128
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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