BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14604139 · Received June 6, 2022

    Report

    Report Number
    1125230-2022-00024
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    April 18, 2022
    Report Date
    June 24, 2022
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). SAMPLES WERE ONLY RECENTLY RECEIVED FROM THE CUSTOMER. THE EVALUATION IS STILL IN PROGRESS. AS SOON AS THE INVESTIGATION OF THE ALLEGED MALFUNCTION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE RACK 454322/B210533A, WHICH EXPIRED ON MAY 8, 2022. NO CUSTOMER PICTURES WERE PROVIDED. NO FURTHER INFORMATION/CLARIFICATION WAS PROVIDED BY THE CUSTOMER. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS. UNFORTUNATELY, WITH THE CUSTOMER RETURNED SAMPLES BEING PAST EXPIRATION UPON RECEIPT, CONCLUSIVE RESULTS WERE UNABLE TO BE GATHERED. PREVIOUS TESTING FOR THIS MATERIAL/BATCH, PRIOR TO EXPIRATION, WAS WITHIN SPECIFICATION, AND THERE ARE NO INDICATIONS OF DEVIATIONS DURING THE MANUFACTURING PROCESS. THE CAUSE FOR THE EVENT CANNOT BE DETERMINED. CORRECTED DATA: G1: CORRECTED EMAIL ADDRESS; H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER STATES HAVE BEEN HAVING ISSUES WITH TUBES NOT FILLING ALL THE WAY. THEY HAVE PULLED THE TUBES FROM THE SHELVES AND THE GRAND TOTAL OF BAD TUBES FOR ITEM IS 1,835. THE LAB FIRST REPORTED THIS ISSUE (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889523 VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454322 B210533A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown