BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7597903 · Received June 13, 2018

    Report

    Report Number
    1024879-2018-00970
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    January 3, 2018
    Report Date
    May 25, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 5316737; MEDICAL DEVICE EXPIRATION DATE: 11/30/2016; DEVICE MANUFACTURE DATE: 11/12/2015; MEDICAL DEVICE LOT #: 7285757; MEDICAL DEVICE EXPIRATION DATE: 10/31/2018; DEVICE MANUFACTURE DATE: 10/12/2017; MEDICAL DEVICE LOT #: 7153850; MEDICAL DEVICE EXPIRATION DATE: 05/31/2018; DEVICE MANUFACTURE DATE:06/02/2017; MEDICAL DEVICE LOT #: 7223923; MEDICAL DEVICE EXPIRATION DATE: 07/31/2018; DEVICE MANUFACTURE DATE: 08/11/2017; MEDICAL DEVICE LOT #: 7313631; MEDICAL DEVICE EXPIRATION DATE: 10/31/2018; DEVICE MANUFACTURE DATE: 11/09/2017; MEDICAL DEVICE LOT #: 6354674; MEDICAL DEVICE EXPIRATION DATE: 12/31/2017; DEVICE MANUFACTURE DATE: 12/19/2016; MEDICAL DEVICE LOT #: 7222663; MEDICAL DEVICE EXPIRATION DATE: 07/31/2018; DEVICE MANUFACTURE DATE: 08/10/2017; MEDICAL DEVICE LOT #: 7251910; MEDICAL DEVICE EXPIRATION DATE: 08/31/2018; DEVICE MANUFACTURE DATE: 09/08/2017. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH A CAPA TO IDENTIFY THE POTENTIAL ROOT CAUSE(S).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR SEPARATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441458 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 7285755 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other