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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD / CAREFUSION 2200, INC 4 MM V. MUELLER RONGEUR, MANUAL

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BD / CAREFUSION 2200, INC 4 MM V. MUELLER RONGEUR, MANUAL Back to Search Results
Model Number NL6052
Device Problem Difficult to Open or Close (2921)
Patient Problem Insufficient Information (4580)
Event Date 09/16/2020
Event Type  Injury  
Event Description
Mouth of instrument did not close properly when in use. Fda safety report id # (b)(4).
 
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Brand Name4 MM V. MUELLER
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
BD / CAREFUSION 2200, INC
franklin lakes NJ 07417
MDR Report Key10837640
MDR Text Key216409899
Report NumberMW5097859
Device Sequence Number1
Product Code HAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL6052
Device Catalogue NumberNL6052
Device Lot NumberB20XWD
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
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