BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES

    MDR report key: 9716884 · Received February 17, 2020

    Report

    Report Number
    1917413-2020-00129
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 28, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679213
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OPEN PACKAGE, FOREIGN MATTER, MISSING CAP AND LABEL LIFT WITH THE INCIDENT LOT 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 THE LABEL LIFT ISSUE THROUGH CAPA#1064141 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 29 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES HAD PARTIALLY PEELED OFF LABELS, 2 TUBES HAD BLACK FOREIGN MATTER IN THEM, AND 5 TUBES WERE MISSING THEIR CAPS. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9220485. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OPEN LABEL = 29 SP PLASTIC ENCAPSULATES TEAR PRODUCTS = 11 SP, BLACK POINT = 2 SP AND NO LID = 5 SP".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K945952. PMA / 510(K)#: K901449. 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 29 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES HAD PARTIALLY PEELED OFF LABELS, 2 TUBES HAD BLACK FOREIGN MATTER IN THEM, AND 5 TUBES WERE MISSING THEIR CAPS. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9220485. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OPEN LABEL = 29 SP. PLASTIC ENCAPSULATES TEAR PRODUCTS = 11 SP. BLACK POINT = 2 SP. NO LID = 5 SP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181838 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367921 9220485 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other