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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC BIOPSY NEEDLE KIT

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CAREFUSION, INC JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC BIOPSY NEEDLE KIT Back to Search Results
Model Number BCTM3411
Device Problem Break (1069)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/28/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial emdr submission. A follow up emdr will be submitted upon completion of investigation. (b)(4).
 
Event Description
Customer reported verbally via telephone call that the plastic hub broke and exposed the metal tip which jammed into the physician's hand. The patient being treated has (b)(6), it did not appear that the skin of the doctor was broken but they are performing a series of tests to be certain. Additional information received (b)(6) 2017: please add to your notes the patient is positive for (b)(6) as well as (b)(6). There was no impact to the patient as a result of this incident. The physician is a (b)(6) male. His initials are (b)(6). No other medical intervention was done to the physician beyond lab testing. Additional information received (b)(6) 2017: medical intervention initial (b)(6) testing as well as follow up testing on pathologist in coming months user harm it is yet to be determined if pathologist who was using device has been infected with (b)(6). Description of event pathologist was collecting bone marrow sample. As he was applying pressure on the acquisition cradle, the white plastic hub slid down the cradle exposing the metal tip. This metal tip went into the palm of the pathologist's hand. We don't think the skin was broken, but as stated above follow-up testing is being performed.
 
Manufacturer Narrative
(b)(4) follow up emdr submission for device evaluation. One cradle was returned for analysis. Visual inspection confirmed that the hub of the cradle had been pushed down, exposing the top tip of the cradle. Therefore the reported defect was confirmed. Additional inspection confirmed that sufficient adhesive was present on the hub/cradle interface. Pressure was applied to the hub in order to further advance it down the cradle, and no sources of the issue were identified. A device history record review was performed for lot 0000980820. No issues were found, indicating that manufacturing procedures were properly performed, and subsequent quality inspections were passed. Visual inspection of the returned cradle confirmed that the hub had been pushed down, exposing the top of the cradle cannula. Adequate adhesive on the hub was observed during sample evaluation, and further exposure of the cannula did not reveal other potential causes for the defect. Therefore, a root cause could not be established. The manufacturer is to be made aware of the complaint by quality notification, which has been sent.
 
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Brand NameJAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC
Type of DeviceBIOPSY NEEDLE KIT
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6232685
MDR Text Key64171261
Report Number1625685-2017-00270
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K913306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBCTM3411
Device Lot Number0000980820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2016
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

Patient Treatment Data
Date Received: 01/09/2017 Patient Sequence Number: 1
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