BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 9554815 · Received January 6, 2020

    Report

    Report Number
    9617032-2019-01616
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 7, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR GEL OUTSIDE TUBE AND ALMOST NO GEL ON THE INSIDE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND GEL OUTSIDE TUBE AND ALMOST NO GEL ON THE INSIDE WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND CONTAINING INSUFFICIENT GEL BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE IS AN UNUSUAL GEL DISTRIBUTION THAT WAS NOTICED FOLLOWING THE DISCOVERY OF A TUBE THAT HAD GEL ON THE OUTSIDE OF THE TUBE (IT STUCK TO THE SAMPLER'S HANDS) AND ALMOST NO GEL ON THE INSIDE. AFTER A SMALL INTERNAL INVESTIGATION, HERE IS OUR FINDING ON THE LOT CONCERNED (LOT 9273512): OUTSIDE THE TUBE ALMOST NO LONGER HAVING GEL, SOME HAVE A GEL TRAIL ALONG THE HEIGHT OF THE TUBE. WE UNCORKED SOME OF THESE TUBES AND THERE WAS SYSTEMATICALLY GEL INSIDE THE CAP. SOME TUBES, OF THE SAME POLYSTYRENE RACK AS THE PREVIOUS ONES, HAVE BUBBLES AT THE GEL LEVEL, SOMETIMES UP TO TWICE AS MUCH VOLUME AS ON THE OTHER TUBES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND CONTAINING INSUFFICIENT GEL BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE IS AN UNUSUAL GEL DISTRIBUTION THAT WAS NOTICED FOLLOWING THE DISCOVERY OF A TUBE THAT HAD GEL ON THE OUTSIDE OF THE TUBE (IT STUCK TO THE SAMPLER'S HANDS) AND ALMOST NO GEL ON THE INSIDE. AFTER A SMALL INTERNAL INVESTIGATION, HERE IS OUR FINDING ON THE LOT CONCERNED (LOT 9273512): OUTSIDE THE TUBE ALMOST NO LONGER HAVING GEL, SOME HAVE A GEL TRAIL ALONG THE HEIGHT OF THE TUBE. WE UNCORKED SOME OF THESE TUBES AND THERE WAS SYSTEMATICALLY GEL INSIDE THE CAP. SOME TUBES, OF THE SAME POLYSTYRENE RACK AS THE PREVIOUS ONES, HAVE BUBBLES AT THE GEL LEVEL, SOMETIMES UP TO TWICE AS MUCH VOLUME AS ON THE OTHER TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18917 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 9273512 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other