BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9593226 · Received January 15, 2020

    Report

    Report Number
    1024879-2020-00004
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    October 23, 2019
    Report Date
    April 6, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 BOWED TUBES WITH THE INCIDENT LOT WAS OBSERVED, HOWEVER, THE FAILURE MODE FOR ADDITIVE ABNORMALITY WAS NOT OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND BOWED TUBES AND ADDITIVE ABNORMALITY WERE 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 H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAVING MOLDING DEFECTS AND THE ADDITIVE IS ABNORMAL. THIS OCCURRED ON (B)(4) OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367988, BATCH NO. 9213124 -IT IS REPORTED VACUTAINER IS BOWED AND ADDITIVE IS "GOOPY" APPEARING. REPORTING MORE AFFECTED BD TUBES. QUALITY ISSUE FROM BD. SOME ARE SO CROOKED, THEY WON'T GO IN THE CENTRIFUGE. I REPORTED THIS SEVERAL MONTHS AGO, AND MORE ARE SHOWING UP. SPOKE WITH THE CUSTOMER. SHE STATED THEY RECEIVED TUBES IN OCTOBER AND THE TUBES WERE BENT, AND THE GEL LOOKED MELTED. SHE STATED THAT A REPORT WAS FILED INTERNALLY.

    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 WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAVING MOLDING DEFECTS AND THE ADDITIVE IS ABNORMAL. THIS OCCURRED ON 50 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367988, BATCH NO. 9213124. IT IS REPORTED VACUTAINER IS BOWED AND ADDITIVE IS "GOOPY" APPEARING. REPORTING MORE AFFECTED BD TUBES. QUALITY ISSUE FROM BD. SOME ARE SO CROOKED, THEY WON'T GO IN THE CENTRIFUGE. I REPORTED THIS SEVERAL MONTHS AGO, AND MORE ARE SHOWING UP. SPOKE WITH THE CUSTOMER. SHE STATED THEY RECEIVED TUBES IN OCTOBER AND THE TUBES WERE BENT, AND THE GEL LOOKED MELTED. SHE STATED THAT A REPORT WAS FILED INTERNALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57201 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367988 9213124 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other