BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19266037 · Received May 8, 2024

    Report

    Report Number
    3003560965-2024-00003
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Report Date
    April 27, 2024
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    JKA
    UDI-DI
    10885380182945
    PMA / PMN Number
    K172763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF CUSTOMER FEEDBACK, PERSONNEL FROM QUALITY, PRODUCTION AND OTHER DEPARTMENTS WERE INVOLVED IN THE INVESTIGATION PERFORMED INCLUDING RETAINED SAMPLING INSPECTION ON 2024.03.11, A SIMULATED BLOOD COLLECTION SAMPLING PROCEDURE AS WELL AS THE ALCOHOL AND IODINE COMPATIBILITY WAS PERFORMED, NO ABNORMITY WAS FOUND. . DETAILS ARE PROVIDED BELOW: ON 2024.03.11, 20 PIECES 20G*19 MM PRODUCTS WERE SAMPLED FROM RETAINED SAMPLE LOT NO. 220725 FOR APPEARANCE INSPECTION, THE TRANSPARENT PACKAGE ALLOWS OBSERVATION OF THE PRODUCT APPEARANCE, AND THEN 10 PCS WERE SAMPLED FROM 20 PCS FOR FURTHER SIMULATED CLINICAL BLOOD COLLECTION PROCEDURE, NO ADAPTER BREAKAGE WAS OBSERVED, AND FURTHER INSPECTION WERE PERFORMED FOR 5 PCS AFTER SIMULATED USE FOR STREE CRACKING TEST AS PER ISO 594-2, NO BREAKAGE WAS FOUND. BASED ON THE CUSTOMER FEEDBACK, THE RETURNED PICTURES WERE ANALYZED BY THE TECHNICAL PERSONNEL WHO CONSIDERED IT TO BE RELEVANT WITH USING DISINFECTANT USED FOR THE ADAPTER INCLUDING ALCOHOL, IODINE ALCOHOL, THREE GROUPS OF TESTS WERE ARRANGED FOR ALCOHOL WIPING, IODINE ALCOHOL WIPING, AND ALCOHOL IMMERSION FOR 24 HOURS, NO BREAKAGE WAS OBSERVED. FURTHER INFORMATION SUCH AS SAMPLES RETURNED IS NEEDED FOR THE ROOT CAUSE DETERMINATION, INTERNAL REPORT (B)(4) AND RELEVANT DOCUMENTS COULD BE PROVIDED UPON REQUEST.

    Description of Event or Problem · 0

    PLEASE FIND A NEW COMPLAINT ATTACHED FROM A CARDINAL CUSTOMER REGARDING A BROKEN LUER HUB. BASED ON THE DESCRIPTION AND LOT INFORMATION PROVIDED IT APPEARS TO BE ANOTHER ALCOHOL-RELATED ISSUE, BUT WE WILL REQUEST ADDITIONAL INFORMATION ON HOW IT WAS USED AND WHAT IT WAS USED WITH AND SHARE ALL FEEDBACK WITH YOU ONCE WE RECEIVE A RESPONSE FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773043 CARDINAL HEALTH BLOOD COLLECTION ADAPTER JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 220725 10885380182945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 20GX19MM BLOOD COLLECTION ADAPTER LOT NO. 220725