BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SPIKE CONNECTOR

    MDR report key: 15612366 · Received October 15, 2022

    Report

    Report Number
    3003152976-2022-00466
    Event Type
    Malfunction
    Date Received
    October 15, 2022
    Date of Event
    September 21, 2022
    Report Date
    December 1, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS 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 PIECE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 30 BD PHASEAL¿ SPIKE CONNECTORS EXPERIENCED SPONTANEOUS DISCONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BONDING OF THE SPIKE PART AND THE CONNECTOR WAS SEPARATED (THESE TWO PARTS HAVE NOT BEEN BONDED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 30 BD PHASEAL¿ SPIKE CONNECTORS EXPERIENCED SPONTANEOUS DISCONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BONDING OF THE SPIKE PART AND THE CONNECTOR WAS SEPARATED (THESE TWO PARTS HAVE NOT BEEN BONDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857279 BD PHASEAL¿ SPIKE CONNECTOR INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2201210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown