BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE-FEMALE L.LOCK CAP - ORANGE

    MDR report key: 12132264 · Received July 7, 2021

    Report

    Report Number
    2243072-2021-01823
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 5, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A TP-MF-O PRODUCT WAS NOT RETURNED FOR INVESTIGATION IN THIS INSTANCE; HOWEVER THE CUSTOMER INDICATES THAT THE PACKAGING IS DIFFICULT TO HANDLE, WHICH MAKES IT DIFFICULT TO REMOVE THE PRODUCTS WITHOUT COMPROMISING THEIR STERILITY. THE CAPS DON'T SEEM TO FIT ONTO THE CONNECTING PRODUCTS EASILY. THERE WAS LEAKAGE BETWEEN THE CONNECTION OF THE CAP AND AN UNKNOWN CATHETER. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, ZIBO QIAOSEND MEDICAL ARTICLES CO LTD, FOR INVESTIGATION; HOWEVER THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED FEEDBACK WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE TP-MF-O PRODUCT IN THE PAST 12 MONTHS. QIAOSEND ARE THE LEGAL MANUFACTURER OF THIS DEVICE AND HAVE THE RESPONSIBILITY FOR ASSESSING THE CLINICAL RISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MALE-FEMALE L.LOCK CAP - ORANGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUALITY LESS GOOD THAN THE OLD CAPS/PLUGS. WHEN USING A CATHETER, YOU CAN CLOSE THE CLAMPS EXTRA SO THAT THEY DO NOT LEAK, BUT UNFORTUNATELY THIS IS NOT POSSIBLE WHEN USING THE FISTULA NEEDLES (WHICH MEANS THEY OFTEN LEAK). THREAD SEEMS TO FIT LESS WELL, SO EXTRA ALERTNESS IS NEEDED TO USE THIS CAP! THEY ARE A LOT LESS STURDY, YOU CAN PRESS THEM IN THAT WAY. NO MORE RIDGES, WHICH MEANS LESS GRIP. THE PACKAGING IS MORE DIFFICULT TO HANDLE, MAKING IT DIFFICULT TO REMOVE CAPS STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025523 MALE-FEMALE L.LOCK CAP - ORANGE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1