BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION ADAPTER C100

    MDR report key: 13953228 · Received March 30, 2022

    Report

    Report Number
    3003152976-2022-00119
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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: NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110233, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS NO DAMAGE OR OTHER DEFECTS OBSERVED ON ANY OF THE INFUSION ADAPTERS. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THAT ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. ALL RETAINED SAMPLES UNDERWENT THESE EVALUATIONS AND PRODUCT WAS VERIFIED TO MEET REQUIRED LIMITS, INCLUDING PROPER SPIKE LENGTH AND DIAMETER. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED BD PHASEAL¿ INFUSION ADAPTER C100 SUFFERED A COMPONENT SEPARATION, RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE SPIKE BBRAUN INFUSION LINE INTO INFUSION ADAPTOR . WHEN BAXTER SOFT BAG WAS LIFTED UP , THE INFUSION ADAPTOR FELL OFF FROM THE BAG."

    Description of Event or Problem · 0

    IT WAS REPORTED BD PHASEAL¿ INFUSION ADAPTER C100 SUFFERED A COMPONENT SEPARATION, RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE SPIKE BBRAUN INFUSION LINE INTO INFUSION ADAPTOR. WHEN BAXTER SOFT BAG WAS LIFTED UP , THE INFUSION ADAPTOR FELL OFF FROM THE BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346038 BD PHASEAL¿ INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515306 2110233 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown