BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 3.5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X75 REDCAP-YELLOWRING

    MDR report key: 10613450 · Received October 1, 2020

    Report

    Report Number
    1125230-2020-00026
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Report Date
    October 29, 2020
    Manufacturer
    GREINER BIO-ONE NA INC
    Product Code
    JKA
    PMA / PMN Number
    K960858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GBO COMPLAINT: (B)(4). RECEIVED 7RKS AND 122PCS 454067P/B1911338 AND 38PCS 454067P/B200135K FOR EVALUATION. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY, LEVEL MARK, FILLING LEVEL 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 AND HAD THE CORRECT FILL GUIDE LINE POSITION. GREINER FILL MARK PROVIDES A VISUAL CONTROL OPPORTUNITY FOR THE PHLEBOTOMIST AND FOR THE LAB PERSONNEL TO CHECK FOR PROPER VOLUME COLLECTION OF SPECIMEN. 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. NO DEVIATIONS COULD BE OBSERVED IN THE SAMPLES. COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 0

    CUSTOMER STATES NOT PROPERLY SUCTIONING.

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT: (B)(4). WE DO HAVE FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. NO PHOTOS WERE PROVIDED BY THE CUSTOMER. WE RECEIVED UNUSED SAMPLES FROM SAME LOT / MATERIAL FOR THE EVALUATION BY CUSTOMER. A REVIEW OF QUALITY, PRODUCTION AND MAINTENANCE RECORDS REVEALED NO DEVIATION IN RELATION TO THE REPORTED ERROR. A DEVICE EVALUATION IS ANTICIPATED AND NOT YET BEGUN. WE WILL FILE SUPPLEMENT REPORT UPON COMPLETION OF SAMPLE EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER STATES NOT PROPERLY SUCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075661 VACUETTE TUBE 3.5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X75 REDCAP-YELLOWRING TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA GREINER BIO-ONE NA INC 454067P B1911338, B200135K

    Patients

    Seq Age Sex Outcome Treatment
    1