BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 6 ML LH LITHIUM HEPARIN 13X100 GREEN CAP-BLACK RING, NON-RIDGED

    MDR report key: 17551020 · Received August 15, 2023

    Report

    Report Number
    1125230-2023-00039
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Report Date
    August 15, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960857
    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

    COMPLAINT STATEMENT (B)(4): RECEIVED 9PCS 456088/B220734D FOR EVALUATION. RECEIVED CUSTOMER PICTURE. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. 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. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY AND DRAW VOLUME ACCORDING TO ISO 6710 'SINGLE USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION' AND CLSI GP39-A6 REGULATIONS FOR 'EVACUATED TUBES AND ADDITIVES FOR BLOOD SPECIMEN COLLECTION'. TUBES WERE VERIFIED TO BE CORRECTLY ASSEMBLED WITH NO DEVIATIONS OBSERVED. BOTH STANDARDS SPECIFY THE DRAW VOLUME TO BE WITHIN +/- 10% RANGE OF THE NOMINAL FILL VOLUME. 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. THE ALLEGED MALFUNCTION COULD NOT BE DUPLICATED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE TUBES ARE NOT FILLING COMPLETELY. THE CUSTOMER PROVIDED A PHOTO WHICH THEY ADVISED IS AN UNDERFILLED TUBE; APPROXIMATELY 1.3ML BELOW THE FILL MARK. THE CUSTOMER ADVISED TO FILL THE TUBE COMPLETELY THEY MUST COLLECT THE BLOOD WITH A SYRINGE AND FORCE FILL THE LAST 1ML OF BLOOD. THE CUSTOMER REPORTED THE INCIDENT OCCURRED SEVERAL TIMES WHILE THEY FOLLOW ALL PHLEBOTOMY BEST PRACTICES AND ARE PERFORMING VENIPUNCTURES ON HEALTHY PATIENT POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246865 VACUETTE® TUBE 6 ML LH LITHIUM HEPARIN 13X100 GREEN CAP-BLACK RING, NON-RIDGED EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456088 B220734D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown