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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX ECHO CT W/4IN TUOHY ULTRA 360 SET ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL INC. CONTIPLEX ECHO CT W/4IN TUOHY ULTRA 360 SET ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 331768
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2019
Event Type  malfunction  
Event Description
Anesthesia staff received a box of echo pain block needle sets which were labeled "not for human use" by small pink sticker on the box. This product was sent to the anesthesia department as a sample product. B braun vendor removed the sticker and took the box with her. No patient contact. Manufacturer response for echo pain block needle set, conti echo ct w/4in tuohy ultra 360 set (per site reporter). B. Braun representative notified of event being reported to medsun. Manufacturer rep retrieved our box of 10 echo pain block needle sets. Lot number, 0061671793 retrieved from manufacturer rep to finalize facility report.
 
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Brand NameCONTIPLEX ECHO CT W/4IN TUOHY ULTRA 360 SET
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown PA 18109
MDR Report Key8939602
MDR Text Key155815795
Report Number8939602
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/24/2019,07/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number331768
Device Lot Number0061671793
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2019
Event Location Hospital
Date Report to Manufacturer08/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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