BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBES EDTA

    MDR report key: 12864177 · Received November 23, 2021

    Report

    Report Number
    1125230-2021-00087
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Report Date
    December 21, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K042927
    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

    RECEIVED 1PC. 454209/B210834X FOR EVALUATION. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCHES. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED EVENT. CUSTOMER SAMPLE WAS TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY, DRAW VOLUME AND ADDITIVE CONTENT 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'. TUBE WAS VERIFIED TO BE CORRECTLY ASSEMBLED. 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 SAMPLE. THE TUBE TESTED FILLED WITHIN THE +/-10% TOLERANCE RANGE. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN TESTED SAMPLE. NO DEVIATIONS COULD BE DUPLICATED IN THE CUSTOMER RETURNED SAMPLE.

    Additional Manufacturer Narrative · 0

    (B)(6): NO DATE OF THE EVENT COULD BE OBTAINED FROM THE CUSTOMER. RECENTLY SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR EVALUATION. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER STATES INCREASED AMOUNT OF CLOTTED LAVENDER TUBES. DIRECT OBSERVATIONS AND TRAINING HAVE BEEN DONE REGARDING PROPER TUBE INVERSIONS. THERE HAVE BEEN 3 OCCURRENCES. CLOTTING DOES NOT OCCUR WHEN A PARTICULAR DEVICE IS USED FOR COLLECTION. THE TUBES ARE INVERTED THE RECOMMENDED NUMBER OF TIMES AS PER IFU. THE TUBES ARE PROPERLY FILLED TO +/-10% OF FILL MARK. NO PHOTOS ARE AVAILABLE. 1 TUBE AVAILABLE TO RETURN OF LOT B210834X. I WILL REQUEST THE CUSTOMER RETURN THIS TUBE. LOT B21093GK NO TUBES AVAILABLE TO RETURN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764133 VACUETTE BLOOD COLLECTION TUBES EDTA EVACUATED BLOOD COLLECTION TUBES JKA GREINER BIO-ONE NA INC. 454209 B210834X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown