• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION 2200, INC V. MUELLER RONGEUR, MANUAL Back to Search Results
Model Number NL3785-164
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2018
Event Type  malfunction  
Event Description
Number 1 kerrison instrument used during posterior cervical instrumentation. Tip of kerrison noted to have broken off during procedure. Radiographic confirmation obtained that tip of instrument was not retained in patient. Suction filter was radiographed and tip found to be seated in filter of the suction machine. Cpd (central processing department) manager notified. Broken instrument isolated w/ suction filter and given to central processing department who dismantled suction filter and sifted the piece out.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameV. MUELLER
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION 2200, INC
75 north fairway drive
vernon hills IL 60061
MDR Report Key7475432
MDR Text Key106988648
Report Number7475432
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/16/2018,04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL3785-164
Device Catalogue NumberNL3785-164
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/16/2018
Event Location Hospital
Date Report to Manufacturer04/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-