BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ CONTAINMENT TUBE

    MDR report key: 8908226 · Received August 19, 2019

    Report

    Report Number
    2243072-2019-01772
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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 HEMOLYSIS WITH THE INCIDENT LOT WAS OBSERVED. HOWEVER, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. HEMOLYSIS CAN BE CAUSED BY MANY SOURCES, INCLUDING CERTAIN PATIENT PATHOLOGICAL CONDITIONS, IMPROPER SPECIMEN COLLECTION, SPECIMEN PROCESSING, AND SPECIMEN TRANSPORT. SPECIMEN COLLECTION FACTORS THAT CAN CONTRIBUTE TO HEMOLYSIS RANGE FROM PROLONGED TOURNIQUET TIME AND IMPROPER VENIPUNCTURE TECHNIQUE TO TRANSFERRING A SAMPLE FROM A SYRINGE DRAW OR IV CATHETER. SPECIMEN PROCESSING FACTORS INCLUDE VIGOROUS MIXING OR SHAKING OF THE SPECIMEN, NOT ALLOWING THE SPECIMEN TO CLOT FOR THE RECOMMENDED AMOUNT OF TIME, PROLONGED CONTACT OF SERUM OR PLASMA WITH CELLS, AND EXPOSURE TO EXCESSIVE HEAT OR COLD. FINALLY, MECHANICAL TRAUMA AND OTHER ADVERSE CONDITIONS DURING TRANSPORT OF TUBES CAN RESULT IN HEMOLYSIS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE UNSPECIFIED BD¿ CONTAINMENT TUBE HAS BEEN FOUND EXPERIENCING POOR GEL SEPARATOR MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN; BATCH NO: UNKNOWN. IT WAS REPORTED THE TUBE HAD POOR GEL SEPARATION NO AFTER THE SPIN THE GEL IS ON TOP OF THE SERUM AND BLOOD CELLS. IN OTHER WORDS THE GEL IN THAT TUBE HAS A LOWER DENSITY THAN THE BLOOD AND SERUM. I CAN¿T BE UNDER CENTRIFUGATION. THE RBCS ARE ON THE BOTTOM, THEN THE SERUM AND THE GEL IS ON THE TOP. THE TUBES ARE CENTRIFUGED AT 4500G FOR 3 MINUTES.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE UNSPECIFIED BD¿ CONTAINMENT TUBE HAS BEEN FOUND EXPERIENCING POOR GEL SEPARATOR MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. IT WAS REPORTED THE TUBE HAD POOR GEL SEPARATION. NO AFTER THE SPIN THE GEL IS ON TOP OF THE SERUM AND BLOOD CELLS. IN OTHER WORDS THE GEL IN THAT TUBE HAS A LOWER DENSITY THAN THE BLOOD AND SERUM. I CAN¿T BE UNDER CENTRIFUGATION. THE RBCS ARE ON THE BOTTOM, THEN THE SERUM AND THE GEL IS ON THE TOP. THE TUBES ARE CENTRIFUGED AT 4500G FOR 3 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698783 UNSPECIFIED BD¿ CONTAINMENT TUBE CONTAINMENT TUBE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other