BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SPIKE CONNECTOR (C180J)

    MDR report key: 12862278 · Received November 23, 2021

    Report

    Report Number
    3003152976-2021-00783
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    January 18, 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

    H6: INVESTIGATION SUMMARY: SAMPLE AND PHOTO RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, NO DEFECTS OR PROBLEMS WERE OBSERVED. IT IS NOTED THAT THE LIQUID IN THE BAG DOES NOT EXIT BETWEEN THE SPIGOT AND THE SPIGOT PORT, BUT EXITS BETWEEN THE RUBBER PLUG AND THE SPIGOT. THE C180J SPIGOT DID NOT HAVE ANY DEFECTS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2102714, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. FIVE RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, AND LEAKAGE TEST PERFORMED, NO DEFECTS OR ISSUES WERE OBSERVED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. BASED ON THE AVAILABLE INFORMATION AND SAMPLE EVALUATION, WE ARE UNABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) LEAKED CALSED AT THE SPIKE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING PREPARATION OF CALSED (ANTICANCER AGENT) AT THE DEPARTMENT OF PHARMACY, NO PARTICULAR PROBLEM WAS OBSERVED. THE PREPARED INFUSION BAG WAS TRANSPORTED TO A HOSPITAL WARD WHERE LEAKAGE WAS DISCOVERED. THE FLUID WAS LEAKING FROM AROUND THE CONNECTION BETWEEN THE SPIKE AND THE CONNECTOR."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) LEAKED CALSED AT THE SPIKE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DURING PREPARATION OF CALSED (ANTICANCER AGENT) AT THE DEPARTMENT OF PHARMACY, NO PARTICULAR PROBLEM WAS OBSERVED. THE PREPARED INFUSION BAG WAS TRANSPORTED TO A HOSPITAL WARD WHERE LEAKAGE WAS DISCOVERED. THE FLUID WAS LEAKING FROM AROUND THE CONNECTION BETWEEN THE SPIKE AND THE CONNECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760036 BD PHASEAL¿ SPIKE CONNECTOR (C180J) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2102714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown