BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75

    MDR report key: 11761305 · Received May 3, 2021

    Report

    Report Number
    1125230-2021-00043
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Report Date
    May 3, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4): A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. RECEIVED 2RK 454322/B200735B FOR EVALUATION. RECEIVED CUSTOMER PICTURES. NO FURTHER INFORMATION OR CLARIFICATION WAS RECEIVED FROM THE CUSTOMER ON "VARIANCES IN THE AMOUNT OF ANTICOAGULANT". WE HAVE NO FURTHER INVENTORY OF 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, FILLING LEVEL, DRAW VOLUME AND ADDITIVE 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. 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. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. THE COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 0

    CUSTOMER STATES THEIR EMERGENCY DEPARTMENT CLAIMS TUBES ARE UNDERFILLING. LABORATORY MANAGER STATES THE LAB PHLEBOTOMISTS HAVE NO UNDERFILLING ISSUES, BUT HAVE SEEN TUBES WITH VARIANCES IN THE AMOUNT OF ANTICOAGULANT IN THE TUBE. THIS FACILITY IS APPROXIMATELY 5000 FT IN ELEVATION AND HAS BEEN USING 454323 (HIGH ALTITUDE) TUBE UNTIL PRODUCT WENT ON BACKORDER. 454322 WAS THEN SUBSTITUTED AND ER BEGAN HAVING UNDERFILLING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663981 VACUETTE TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454322 B200735B

    Patients

    Seq Age Sex Outcome Treatment
    1