BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 2 ML 9NC AND VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE

    MDR report key: 17557180 · Received August 16, 2023

    Report

    Report Number
    1125230-2023-00040
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Report Date
    August 16, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT CO23-2100-265: RECEIVED 1PC EACH OF 454322/B23033NN, 454322/B2302359, 454322/B230133Y, 454322/B230433M, 454334/B221136L, 454334/B221033J, 454334/B221033H, 454334/B22113RC, 454334/B221136X, AND 454334/B22093BW FOR EVALUATION. RECEIVED CUSTOMER PICTURE. 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 STATES TUBES ARE UNDERFILLING AND OVERFILLING. A WIDE VARIETY OF COLLECTION DEVICES ARE USED; SBCS AND SYRINGES FROM NURSING AND SBCS AND STRAIGHT NEEDLES FROM PHLEBOTOMY. PHLEBOTOMY USES DISCARD TUBE, BUT UNSURE IF NURSING DOES (EDUCATION HAS BEEN GIVEN). PHLEBOTOMISTS HOLD THE TUBE IN PLACE; UNKNOWN IF NURSING DOES. TUBES ARE RECEIVED FILLED +/-20% AND APPROXIMATELY 23-30% ARE UNDERFILLED. THE ISSUES OCCUR WITH RNS AND A FEW PHLEBOTOMISTS (BUT NO PHLEBS AFTER IN-SERVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483102 VACUETTE® TUBE 2 ML 9NC AND VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE EVACUATED BLOOD COLLECTION TUBES GIM GREINER BIO-ONE NA INC. 454322, 454334 B23033NN, B221136L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown