BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SPIKE CONNECTOR (C180J)

    MDR report key: 15602056 · Received October 13, 2022

    Report

    Report Number
    3003152976-2022-00465
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 20, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    UDI-DI
    00382905153228
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THREE SAMPLES WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE CONNECTOR WAS OBSERVED TO BE DISCONNECTED FROM THE SPIKE. THERE WAS TRACES OF SOLVENT OBSERVED ON THE C35 CONNECTOR PIECES, HOWEVER, IT WAS NOTED TO BE AN INSUFFICIENT AMOUNT, RESULTING IN IMPROPER ASSEMBLY WHICH CAUSED THE PIECES TO DISCONNECT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201210, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, NO ISSUES WERE FOUND. ALTHOUGH WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT WAS LIKELY RELATED TO A FAILURE IN THE DISPENSER THAT DOSES THE SOLVENT, RESULTING IN THE IMPROPER ASSEMBLY OF THE CONNECTOR ONTO THE SPIKE. A PROJECT HAS BEEN INITIATED TO FURTHER INVESTIGATE AND PREVENT ANY REOCCURRENCE OF THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) AND SPIKE SPONTANEOUSLY DISCONNECTED DURING USE. THIS OCCURRED WITH 3 SPIKE CONNECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "UPON CONNECTION, THE SPIKE AND C35 WERE SEPARATED DESPITE THAT NO PARTICULARLY GREAT FORCE WAS APPLIED. THE ON-SIDE HCP STATES THAT THE CONNECTION WAS PERFORMED WHILE HOLDING THE CONNECTOR."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) AND SPIKE SPONTANEOUSLY DISCONNECTED DURING USE. THIS OCCURRED WITH 3 SPIKE CONNECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "UPON CONNECTION, THE SPIKE AND C35 WERE SEPARATED DESPITE THAT NO PARTICULARLY GREAT FORCE WAS APPLIED. THE ON-SIDE HCP STATES THAT THE CONNECTION WAS PERFORMED WHILE HOLDING THE CONNECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889216 BD PHASEAL¿ SPIKE CONNECTOR (C180J) INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. 2201210 00382905153228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown