• 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 JAMSHIDI; BIOPSY NEEDLE

  • 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 JAMSHIDI; BIOPSY NEEDLE Back to Search Results
Model Number TIN3015
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2017
Event Type  malfunction  
Event Description
Patient was undergoing a bone marrow biopsy during which time a bone marrow aspirate needle was inserted into the patient.Reportedly, when the introducer was removed the handle fell off.The procedure reportedly continued and was completed without harm to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JAMSHIDI
Type of Device
BIOPSY NEEDLE
Manufacturer (Section D)
CAREFUSION 2200, INC
400 east foster rd.
mannford OK 74044
MDR Report Key6724858
MDR Text Key80439248
Report Number6724858
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTIN3015
Device Catalogue NumberTIN3015
Device Lot Number100001038740
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/26/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age54 YR
-
-