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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TEMNO NEEDLE BIOPSY COAXIAL 18G X 11CM BIOPSY NEEDLE KIT

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CAREFUSION, INC TEMNO NEEDLE BIOPSY COAXIAL 18G X 11CM BIOPSY NEEDLE KIT Back to Search Results
Model Number CT1811
Device Problem Physical Property Issue (3008)
Patient Problem Needle Stick/Puncture (2462)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). If additional information becomes available a follow up emdr will be submitted. Needle stick/puncture (b)(4). Physical property issue (b)(4).
 
Event Description
Customer reported via email: upon disengaging the biopsy mechanism to expose the specimen, the spring loaded two part handle broke apart and the spring shot out causing the blade to lunge forward sticking the cytologytech. The device handle broke into several pieces. Per customer, no additional information available.
 
Manufacturer Narrative
(b)(4) a review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found. It was confirmed that procedural and functional requirements needed for its release were met. Lot #0000909688 was manufactured on 07-mar-2016. Conclusion(s): customer ¿ sample not returned: based on the investigation results, a probable root cause could not be identified for the reported failure mode since samples were not returned for evaluation. This failure mode will be entered into the complaint tracking system and tracked & trended for future occurrences of any similar failure modes.
 
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Brand NameTEMNO NEEDLE BIOPSY COAXIAL 18G X 11CM
Type of DeviceBIOPSY NEEDLE KIT
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
zona franca las americas
santo domingo
DR
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6350102
MDR Text Key68047810
Report Number9680904-2017-00100
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K902319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCT1811
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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