BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING

    MDR report key: 10729474 · Received October 23, 2020

    Report

    Report Number
    1125230-2020-00034
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Report Date
    November 18, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GBO COMPLAINTS (B)(4): RECEIVED 1RK 456087P/B20083GW FOR EVALUATION. RECEIVED CUSTOMER PICTURE. WE HAVE NO FURTHER COMPLAINTS OF THE MATERIAL/BATCH. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION THE REPORTED EVENT. CUSTOMER SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY, LEVEL MARK, FILLING LEVEL, DRAW VOLUME AND ADDITIVE CONTENT 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. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. NO DEVIATIONS COULD BE OBSERVED IN THE SAMPLES. COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 0

    CUSTOMER STATES THEY ARE EXPERIENCING HEMOLYSIS. THIS IS OCCURRING WITH COLLECTION OF BLOOD FROM IV LINES FROM THE EMERGENCY DEPARTMENT AND THE NUMBER OF HEMOLYZED DRAWS ARE SIGNIFICANT. 9 TIMES OUT OF 10 ARE COMING FROM COLLECTING BLOOD WHEN STARTING AN IV.

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT NO: (B)(4). WE DO NOT HAVE FURTHER INVENTORY FOR THIS MATERIAL/BATCH. WE RECEIVED SAMPLES FROM THE SAME MATERIAL/LOT FROM THE CUSTOMER FOR EVALUATION. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE EXPERIENCING HEMOLYSIS. THIS IS OCCURRING WITH COLLECTION OF BLOOD FROM IV LINES FROM THE EMERGENCY DEPARTMENT AND THE NUMBER OF HEMOLYZED DRAWS ARE SIGNIFICANT. 9 TIMES OUT OF 10 ARE COMING FROM COLLECTING BLOOD WHEN STARTING AN IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196090 VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456087P B20083GW

    Patients

    Seq Age Sex Outcome Treatment
    1