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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 366664
Medical Device Problem Code Short Fill (1575)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/14/2017
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 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 the bd vacutainer® lithium heparin (lh) 37 usp units blood collection tubes were underfilling and the vacuum was not working properly.No serious injury or medical intervention.
 
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Brand Name
BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS 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 Key7571295
Report Number1917413-2018-02187
Device Sequence Number16532915
Product Code JKA
UDI-Device Identifier50382903666640
UDI-Public50382903666640
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K901449
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) 05/10/2018
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 Number366664
Device Lot Number7033560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2017
Initial Report FDA Received Date06/05/2018
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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