BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2 ML FX SODIUM FLUORIDE / POTASSIUM OXALATE 13X75

    MDR report key: 11207666 · Received January 21, 2021

    Report

    Report Number
    8020040-2021-00004
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Report Date
    February 1, 2021
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    JKA
    PMA / PMN Number
    K971239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 6PC 454238/A20043D6 FOR EVALUATION. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND SAMPLES TO OUR AFFILIATED HEADQUARTERS IN AUSTRIA FROM WHICH WE RECEIVE THIS PRODUCT. A REVIEW OF PRODUCTION DOCUMENTATION REVEALED NO DEVIATIONS IN ASSOCIATION WITH THE REPORTED ISSUE. SAMPLES WERE TESTED WITH REGARDS TO LEVEL MARK AND DRAW VOLUME. TUBES WERE VERIFIED TO HAVE THE CORRECT FILL GUIDELINE 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. NO DEVIATION IN DRAW VOLUME, LOW OR HIGH FILL, COULD BE OBSERVED IN THE TESTED SAMPLES. ALL TUBES WERE WITHIN TOLERANCE RANGE. THE COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). THE DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. RETURNED SAMPLES OF THE PRODUCT HAVE NOT YET BEEN EVALUATED. AS SOON AS THE INVESTIGATION IS COMPLETED, WE WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE HAVING ISSUES WITH UNDERFILLING TUBES. THE REPORTS ARE COMING FROM EXPERIENCED LAB PEOPLE. ISSUES OCCURS WITH STRAIGHT NEEDLE, BUTTERFLY, AND SYRINGE WITH TRANSFER DEVICE. NO DISCARD TUBE IS USED FOR A BUTTERFLY DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108237 VACUETTE TUBE 2 ML FX SODIUM FLUORIDE / POTASSIUM OXALATE 13X75 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE GMBH 454238 A20043D6

    Patients

    Seq Age Sex Outcome Treatment
    1