BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 3.5 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 BLUE CAP-BLACK

    MDR report key: 10577396 · Received September 23, 2020

    Report

    Report Number
    1125230-2020-00024
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Report Date
    September 23, 2020
    Manufacturer
    GREINER BIO-ONE NA INC
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT NUMBER: (B)(4). (CUSTOMER PROVIDED THE LOT NUMBERS ASSOCIATED THIS COMPLAINTS ARE B19103PY, B2005373, B200236E, B200136, B200734R, B20033BC) RECEIVED 1RK 454332/B200236E, 2RKS 454332/B200136U,2PCS. 454332/B20033BC, AND 22PCS 454332/B200734R. NO SAMPLES WERE RECEIVED FOR 454332/B19103PY AND 454332/B2005373 FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCHES. A REVIEW OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS REVEALS NO DEVIATIONS IN RELATION TO THE REPORTED EVENT. NO VISUAL DEVIATION IN FILL VOLUME, SPORADIC LOW OR HIGH FILL, COULD BE OBSERVED IN THE TESTED SAMPLES. ALL TUBES TESTED FILLED WITHIN THE +/-10% TOLERANCE RANGE. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. NO DEVIATIONS COULD BE OBSERVED IN THE SAMPLES. COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBES ARE LOSING VACUUM. THE TUBE FAILING IS CAUSING PATIENTS TO HAVE TO BE RECOLLECTED. IT IS AN INCONVENIENCE TO THEIR PATIENTS WHO NEED TO COME BACK IN TO HAVE BLOOD DRAWN MULTIPLE TIMES FOR SAME TEST. FOR OCCURRENCES OF TUBES LOSING VACUUM, CUSTOMER ADVISES THAT THEY WERE HAVING MORE THAN 5 TUBES A DAY. THE LABORATORY STAFF IS TRAINED AND SIGNED OFF ON HOW TO COLLECT TUBES. THEY HAVE BEEN OBSERVED ON APPLYING PROPER PRESSURE TO THE TUBES DURING COLLECTION. IF THEY REINSERT THE TUBE INTO THE HOLDER, MORE TIMES THAN NOT THEY GET BLOOD RETURN AND ARE ABLE TO FILL UP THE TUBES PROPERLY. FOR BLOOD COLLECTION, THEY ARE USING BD STRAIGHT 22G ECLIPSE NEEDLES OR VACUETTE SAFETY BLOOD COLLECTION SETS WITH LAUER ADAPTER. IF A SAFETY BLOOD COLLECTION SET IS USED, A WASTE TUBE IS DRAWN. THIS IS OCCURRING WITH PHLEBOTOMISTS AS WELL AS OTHER DEPARTMENTS AS THEY START IVS FOR PATIENTS. THE ER DEPARTMENT ADVISES THAT 90% OF THEIR BLUE TUBES DO NOT HAVE VACUUM. CUSTOMER STATES RACKS OF TUBES WERE PACKAGED WITH LOOSE WRAPPING, CAUSING TUBES TO COME OUT OF THEIR RACK POSITION WHEN STILL WRAPPED. CUSTOMER PURCHASES BY THE CASE FROM CARDINAL. CUSTOMER ASSUMES THE RACKS OF TUBES ARE COMING IN THE SAME WRAPPING/PACKAGING THAT GREINER SHIPS THEM TO CARDINAL IN. CARDINAL WILL PACK THE RACKS OF TUBES IN BOXES WITH OTHER ITEMS WHEN CARDINAL SHIPS FROM THEIR WAREHOUSE. THE CASES OF TUBES COME IN THEIR ORIGINAL BOXES FROM WHAT THE CUSTOMER CAN SEE BUT UNSURE DUE TO THE RACKS ARE WRAPPED IN SEVERAL DIFFERENT TYPES OF WRAPPING/PACKAGING. SOME RACKS ARE WRAPPED WITH THIN CELLOPHANE AND WRAPPED TIGHTER BUT IT TEARS AND THE TUBES GET LOOSE IN THE BOX. OTHER RACKS OF TUBES ARE IN A THICKER PLASTIC WRAPPING THAT IS LOOSE, AND THE TUBES GET LOOSE WITHIN THE PLASTIC WRAPPING/PACKAGING. CUSTOMER PROVIDED PICTURES OF HOW RACK OF TUBES WAS RECEIVED. CUSTOMER QUESTIONS INTEGRITY OF TUBES DUE TO THE TUBES COMING OUT OF POSITION IN RACK AND IS HAVING VACUUM ISSUES WITH THESE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042408 VACUETTE TUBE 3.5 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 BLUE CAP-BLACK TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT GIM GREINER BIO-ONE NA INC 454332 B19103PY, B2005373, B200236C

    Patients

    Seq Age Sex Outcome Treatment
    1