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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER RONGEUR, MANUAL

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CAREFUSION 2200, INC V. MUELLER RONGEUR, MANUAL Back to Search Results
Model Number NL4261-83
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2020
Event Type  malfunction  
Event Description
The screw came out of the device and went into the patient's surgical field.
 
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Brand NameV. MUELLER
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION 2200, INC
75 north fairway drive
vernon hills IL 60061
MDR Report Key10020254
MDR Text Key189741937
Report Number10020254
Device Sequence Number1
Product Code HAE
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 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL4261-83
Device Catalogue NumberNL4261-83
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2020
Event Location Hospital
Date Report to Manufacturer05/04/2020
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

Patient Treatment Data
Date Received: 05/04/2020 Patient Sequence Number: 1
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