BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 9855650 · Received March 19, 2020

    Report

    Report Number
    1917413-2020-00297
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 28, 2020
    Report Date
    May 11, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 3/20/2020 H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR EMBEDDED FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND EMBEDDED FOREIGN MATTER 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#(B)(4). THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HAVE YOU HAD ANY CUSTOMERS REPORTING WHAT APPEARS TO BE IMPERFECTIONS IN THE TUBE ? THERE ARE BLACK PARTICLES THAT APPEAR TO BE IMBEDDED IN THE PLASTIC? WE ARE SEEING THESE IN THE PST AND SST TUBES. PST LOT #9220492 THE ¿SCRATCHES¿ AROUND THE BLACK DOT IS WHERE WE TRIED TO SCRAPE IT OUT WITH A NEEDLE, SO THE BLACK IS IMPEDED IN THE PLASTIC."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HAVE YOU HAD ANY CUSTOMERS REPORTING WHAT APPEARS TO BE IMPERFECTIONS IN THE TUBE ? THERE ARE BLACK PARTICLES THAT APPEAR TO BE IMBEDDED IN THE PLASTIC? WE ARE SEEING THESE IN THE PST AND SST TUBES. PST LOT #9220492. THE ¿SCRATCHES¿ AROUND THE BLACK DOT IS WHERE WE TRIED TO SCRAPE IT OUT WITH A NEEDLE, SO THE BLACK IS IMPEDED IN THE PLASTIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321460 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367960 9220492 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other