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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367842
Medical Device Problem Code Volume Accuracy Problem (1675)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/06/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for (b)(6) 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 bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes were underfilled.
 
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Brand Name
BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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 Key7495995
Report Number1917413-2018-01265
Device Sequence Number109466
Product Code JKA
UDI-Device Identifier50382903678421
UDI-Public50382903678421
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K981013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source 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 Expiration Date06/30/2018
Device Catalogue Number367842
Device Lot Number7067782
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/06/2017
Initial Report FDA Received Date05/08/2018
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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