BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)

    MDR report key: 14719225 · Received June 16, 2022

    Report

    Report Number
    3003152976-2022-00267
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 26, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150708
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED, AND ADDITIONAL RETAINED SAMPLES CANNOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) EXPERIENCED LEAKAGE BETWEEN THE OPTIMA CONNECTOR AND THE MAGELLAN SAFETY NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 5/19 REPORTED THAT OCCASIONALLY EXPERIENCE LEAKING BETWEEN THE OPTIMA CONNECTOR 515070 AND THE MAGELLAN 25 G X 5/8" SAFETY NEEDLE WHEN ADMINISTERING SUB Q OR IM. THIS ONLY OCCURS WHEN ADMINISTERING VERY VISCOUS CHEMO DRUGS THAT REQUIRE A LOT OF FORCE TO ADMINISTER. THE NURSES WERE NOT ABLE TO AGREE ON HOW MANY TIMES IT HAD OCCURRED OR EVEN THE LAST TIME IT OCCURRED. NO LOT # DATA OR OTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209104 BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 00382905150708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown