BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMALE FOLEY ADAPTER

    MDR report key: 19484613 · Received June 6, 2024

    Report

    Report Number
    MW5155896
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 4, 2024
    Manufacturer
    COOK INCORPORATED
    Product Code
    EYK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POSSIBLE DEFECTIVE FEMALE FOLEY ADAPTER. WE HAVE NOTICED LEAKAGE FROM THE BD PHA SEAL SYSTEM AND THE FEMALE CONNECTOR EVEN WHEN TIGHTEN WELL. THIS HAS CAUSED LOSS OF DRUG DURING ADMINISTRATION AND POTENTIAL CHEMO EXPOSURE TO STAFF AND PATIENT. MANUFACTURER OF THE PRODUCT- COOK MEDICAL. PRODUCT NAME- FEMALE FOLEY ADAPTER. PRODUCT REF NUMBER-053003. PRODUCT LOT NUMBER (IF YOU HAVE IT) - 14742937. A PICTURE OF THE PART OF THE PRODUCT THAT IS LEAKING- YES WILL ATTACH. HAVE ANY PATIENTS BEEN HARMED OR NEEDED ADDITIONAL EVALUATION OR FOLLOWING BECAUSE OF THIS EVENT? ACCORDING TO NURSES AT LEAST THIS HAPPENS OFTEN WITH THIS DEVICE AND THEY PUT CHUX UNDER THE CONNECTION IN CASE OF LEAK. WAS THERE A SPILL KIT ON SITE TO PROPERLY CLEAN THE CHEMO? YES, WE HAVE CHEMO SPILL KIT. DID THIS ISSUE CAUSE A PATIENT TO MISS A ROUND OF CHEMO OR A DELAY IN TREATMENT. NO MISSED DOSES. WAS THE ISSUE WITH PRODUCTS THAT ALL HAD THE SAME LOT NUMBER? NO, WE BELIEVE IT MAY THE PRODUCT ITSELF. HOW MANY DEFECTIVE PRODUCTS HAVE YOU FOUND? I FOUND 3 FROM THIS LOT NUMBER THAT THE PIECE EASILY FELL OUT OF CONNECTOR. WAS THIS REPORTED TO MATERIAL MANAGEMENT? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327067 FEMALE FOLEY ADAPTER CONNECTOR, URETERAL CATHETER EYK COOK INCORPORATED 053003 14742937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown