BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 7451034 · Received April 23, 2018

    Report

    Report Number
    1917413-2018-00967
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    December 8, 2016
    Report Date
    June 8, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE IS CORRECTED TO JKA. PMA / 510(K)# IS CORRECTED TO K981013.

    Additional Manufacturer Narrative · 1

    THERE IS NO MEDICAL DEVICE TYPE FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RETURNED TO MANUFACTURE ON: USED EMAIL DATE IN INTERNAL BD COMMENTS. (B)(6). PMA/510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR (B)(6) WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® EDTA 2K TUBES HAD AN EXTRA FILL LINE AND THAT THE ORIGINAL FILL LINE WAS OUT OF ALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293105 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6161930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other