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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 368589
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/31/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Unknown expiration date.Manufacture date unknown.Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for (b)(4) with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.
 
Event or Problem Description
It was reported that while using the bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes, there was one tube that was difficult to puncture resulting in blood spatter.
 
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Brand Name
BD VACUTAINER® K2 EDTA (K2E) 18 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 Key7503533
Report Number1917413-2018-01391
Device Sequence Number13835173
Product Code JKA
UDI-Device Identifier50382903685894
UDI-Public50382903685894
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
BK980011
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/30/2018
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 Catalogue Number368589
Device Lot Number7016746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/31/2017
Initial Report FDA Received Date05/10/2018
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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