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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 368661
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/05/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.
 
Event or Problem Description
It was reported that bd vacutainer® k2 edta (k2e) 10.8 mg blood collection tubes had fm in the tubes.No report of medical intervention or serious injury.
 
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Brand Name
BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
MDR Report Key7596342
Report Number1917413-2018-01863
Device Sequence Number1754817
Product Code JKA
UDI-Device Identifier50382903686617
UDI-Public50382903686617
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K971449
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date06/30/2017
Device Catalogue Number368661
Device Lot Number5357625
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/05/2016
Initial Report FDA Received Date06/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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