BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100

    MDR report key: 14480457 · Received May 23, 2022

    Report

    Report Number
    1125230-2022-00015
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Report Date
    June 9, 2022
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES FOR EVALUATION HAVE ONLY RECENTLY BEEN RECEIVED FROM THE CUSTOMER. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RECEIVED 15PC 455071P/B21123GQ FOR EVALUATION. RECEIVED CUSTOMER VIDEOS. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. SOME OF THE CUSTOMER SAMPLES WERE EVALUATED IN A BLOOD DRAW. GEL BARRIERS FORMED CORRECTLY, AND GOOD SEPARATION WAS OBSERVED IN THE TESTED SAMPLES WHEN SAMPLES WERE ALLOWED TO CLOT THOROUGHLY AND WERE CENTRIFUGED USING RECOMMENDED GBO PARAMETERS WITHIN 2 HOURS OF COLLECTION. THE APPEARANCE OF THE GEL BARRIERS OF TESTED SAMPLES IS SIMILAR TO THOSE IN PREVIOUS BLOOD DRAWS. THE ALLEGED MALFUNCTION COULD NOT BE DUPLICATED. CORRECTED DATA H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER STATES RBCS MIGRATES THROUGH THE BARRIER (GEL). GEL DOESN'T LOOK AS THICK AS IT NORMALLY DOES IN THESE VIDEOS. THERE HAVE BEEN 2 OCCURRENCES. THE SAMPLES SAT FOR 30 MIN AND THEN CENTRIFUGED. RBCS COMING THROUGH THE BARRIER (GEL) WAS NOTICED BY ANOTHER PSR WHEN TUBE WAS BEING PLACED INTO THE SPECIMEN BAG. THE SAMPLE WAS SPUN FOR THE SECOND TIME. AGAIN, THE RBC CAME THROUGH THE BARRIER. SPECIMEN WAS SPUN FOR THE THIRD TIME TO FILM WHAT WE HAD DISCOVERED. TUBES WERE INVERTED THE APPROPRIATE NUMBER OF TIMES. TUBES WERE ALLOWED TO SIT UPRIGHT FOR 30 MINUTES. THE SPECIMENS WERE CENTRIFUGED FOR 15 MINUTES WITH THE BREAK OF 2 ACCORDING TO THE RECOMMENDATION FROM GREINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171426 VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100 EVACUCATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 455071P B21123GQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown