BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8931139 · Received August 26, 2019

    Report

    Report Number
    1024879-2019-01514
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 8, 2019
    Report Date
    October 8, 2019
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 FOREIGN MATERIAL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND A SMALL PIECE OF CARDBOARD 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.

    Description of Event or Problem · 0

    MATERIAL NO. 367986 BATCH NO. 9030859. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THE TUBE GEL LOOKS LIKE IT HAS MOLD GROWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBE GEL LOOKS LIKE HAS MOLD GROWING ONLY SEEN 1 TUBE WITH THIS ISSUE. CUSTOMER STATES THAT THERE WAS ONLY 1 TUBE IN THE REMAINING CASE OF SST TUBES WITH MOLD IN THE GEL. THE OTHER TUBES APPEAR NORMAL, AND THEY ARE USING THEM WITH NO PROBLEMS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 367986, BATCH NO. 9030859. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THE TUBE GEL LOOKS LIKE IT HAS MOLD GROWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBE GEL LOOKS LIKE HAS MOLD GROWING ONLY SEEN 1 TUBE WITH THIS ISSUE. CUSTOMER STATES THAT THERE WAS ONLY 1 TUBE IN THE REMAINING CASE OF SST TUBES WITH MOLD IN THE GEL. THE OTHER TUBES APPEAR NORMAL, AND THEY ARE USING THEM WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727086 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9030859 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other