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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
Catalog Number 332103
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(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: the customer opened a tray and discovered fluid droplets within the syringe. No injury reported.

 
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Brand NameCONTIPLEX
Type of DeviceNERVE BLOCK TRAY (KIT)
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown 18109
Manufacturer Contact
jonathan severino
861 marcon boulevard
allentown, PA 18109
4842408332
MDR Report Key8612047
MDR Text Key145130872
Report Number2523676-2019-00062
Device Sequence Number1
Product Code OGJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device Catalogue Number332103
Device LOT Number0061638374
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 Received05/02/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2018
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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