BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBES

    MDR report key: 8745381 · Received June 28, 2019

    Report

    Report Number
    1917413-2019-01670
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 13, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679213
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K)#: K945952, K901449. INVESTIGATION SUMMARY: 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 FOREIGN MATTER 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. BD IS REVIEWING SPECIFIC AREAS IN THE MANUFACTURING PROCESS WHERE THE CAUSE OF THIS ISSUE MAY HAVE ORIGINATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "TUBE OF STAIN". 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536403 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8303712 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other