BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3.5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X75

    MDR report key: 16460275 · Received March 1, 2023

    Report

    Report Number
    1125230-2023-00006
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    January 28, 2023
    Report Date
    March 17, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K983952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT CO23-2100-037: RECEIVED CUSTOMER PHOTOS. NO SAMPLES WERE RECEIVED FOR 454067P/B220933Q AND 456073P/B22063LY FOR EVALUATION. WE HAVE NO FURTHER COMPLAINTS ON THESE MATERIALS/BATCHES. THIS CAUSE OF THE ALLEGED MALFUNCTION CANNOT BE DETERMINED. RECEIVED 20PCS OF 456073P/B221136H AND 21PCS OF 454067P/B221035H FOR EVALUATION. WE HAVE NO FURTHER COMPLAINTS ON THESE MATERIALS/BATCHES. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. SAMPLES WERE VISUALLY AND FUNCTIONALLY EVALUATED (FILLED AND CENTRIFUGED AT 1800G FOR 10MIN - MINIMUM OF RECOMMENDED CONDITIONS). NO DEVIATIONS RELATED TO THE REPORTED ERRORS COULD BE OBSERVED IN TESTED SAMPLES. THIS ALLEGED MALFUNCTION CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4). IN ADDITION TO LOT# B221136H, THE CUSTOMER STATED THE FOLLOWING LOTS: B22063LY, EXPIRATION DATE 10/08/2023, DATE OF MANUFACTURE: 06/08/2022. B220933Q, EXPIRATION DATE 12/01/2023, DATE OF MANUFACTURE: 09/01/2022. B221035H, EXPIRATION DATE 01/10/2024, DATE OF MANUFACTURE: 10/11/2022. THE EVALUATION OF SAMPLES IS STILL IN PROGRESS. AS SOON AS THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER STATES SPECIMENS IN TUBES ARE NOT SEPARATING PROPERLY WHEN CENTRIFUGED. THERE HAVE BEEN APPROXIMATELY 10 TUBES AFFECTED. PRIOR TO (B)(6) 2023, PROCESSING DID NOT HAVE ISSUES WITH TUBES NOT SEPARATING CORRECTLY. SPECIMENS WERE COLLECTED FROM DIFFERENT PATIENTS ON DIFFERENT FLOORS AND ED DEPARTMENT. THE TUBES WERE INITIALLY CENTRIFUGED IN DIFFERENT CENTRIFUGES. SPECIMENS ARE EITHER NOT SPINNING ALL THE WAY OR, IF SPUN IN ED LAB AND SENT IN TUBE [PNEUMATIC TUBE] SYSTEM, GEL IS AT THE TOP OF TUBE AND SPECIMEN LOOKS LIKE WHOLE BLOOD - PLASMA AND CELLS MIXED. BIOMED CHECKS THE CENTRIFUGES ON A REGULAR BASIS. CENTRIFUGES HAVE BEEN CHECKED AND ARE SET ACCORDING TO VALIDATED SETTINGS. CUSTOMER WILL RE-CENTRIFUGE TUBES AND SPECIMENS SEEM TO SEPARATE PROPERLY. CUSTOMER HAS NOW PROVIDED PHOTOS FROM 456073P, LOT B22063LY AND B221035H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143036 VACUETTE® TUBE 3.5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X75 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456073P B221136H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown