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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. / CAREFUSION 2200, INC. BECTON, DICKINSON & CO. KERRISON RONGEUR, MANUAL

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BECTON, DICKINSON & CO. / CAREFUSION 2200, INC. BECTON, DICKINSON & CO. KERRISON RONGEUR, MANUAL Back to Search Results
Lot Number 4251-83T
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Event Description
A 3mm z-coat kerrison tip broke routine/proper use. Per scrub rn, broken piece retrieved from surgical incision field and broken piece fits exactly with kerrison instrument. Removed from back table. Broken instrument labeled and sent down to spd on case cart. Fda safety report id# (b)(4).
 
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Brand NameBECTON, DICKINSON & CO. KERRISON
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
BECTON, DICKINSON & CO. / CAREFUSION 2200, INC.
MDR Report Key11107969
MDR Text Key225079004
Report NumberMW5098617
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 12/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4251-83T
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

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