BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION ADAPTER C100J

    MDR report key: 8173989 · Received December 18, 2018

    Report

    Report Number
    3003152976-2018-00552
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    K110023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE SAMPLE WAS EVALUATED BY JFR LAB. NO LEAK WAS FOUND ACCORDING TO THE REPORT. THE SAMPLE WAS EVALUATED BY JFR LAB. ACCORDING TO THE REPORT: SOME LOOSENESS WAS FOUND BETWEEN THE SPIKE NEEDLE AND C100. NO LEAK WAS CONFIRMED AT FIRST ATTEMPT. NO LEAK WAS CONFIRMED AFTER RECONNECTION. THE COMPONENTS ARE MOLDED AT NOLATO. LATER, THEY ARE ASSEMBLED IN SA PLANT. DURING ASSEMBLY PROCESS, THE OPERATOR PERFORMS VISUAL INSPECTION OF THE MEMBRANE, SPIKE PORT, HOUSING AND CAP TO VERIFY THAT PRODUCT IS FREE OF DAMAGES (PROCEDURE PH-304, PH-081). THE OPERATOR TAKES 24 SAMPLES FOR EACH 1.000 UNITS AND VERIFIED THE WELDING OF THE MEMBRANE, CORRECT ASSEMBLY AND QUALITY OF THE COMPONENTS. DURING THE PACKAGING PROCESS OF PHASEAL PRODUCT, VISUAL INSPECTION OF THE PRODUCT IS PERFORMED BY THE OPERATOR ACCORDING TO PH-009 AND PH-307. EIGHT SAMPLES ARE TAKEN FOR VISUAL INSPECTIONS (2 STRIPS) TO VERIFY THE QUALITY OF THE BLISTERS. ON THE OTHER HAND, 100% VISUAL INSPECTION IS PERFORMED FOR ALL PHASEAL PRODUCT BY THE OPERATOR BEFORE PLACE THE PRODUCT IN THE UNIT CASE. DURING THE LOAD OF PRODUCT IN THE UNIT CASES, THE OPERATOR CHECKS THE CORRECT QUALITY OF THE PRODUCT (FREE OF DAMAGES, F.M). IN CASE OF FAULTY PRODUCT, IT IS SENT TO SCRAP. IN CASE OF PACKAGING DEFECTS, SAMPLES ARE PICKED UP AND PACKAGED AGAIN. LEAKAGE TEST IS PERFORMED ACCORDING TO PC-226 TO ENSURE THE QUALITY OF THE MEMBRANE. THE DEFECT WAS NOT CONFIRMED: NO LEAK WAS FOUND IN SAMPLE RECEIVED. AS THE LOT IS UNKNOWN, DHR CANNOT BE REVIEWED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ INFUSION ADAPTER C100J LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ INFUSION ADAPTER C100J LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016592 BD PHASEAL¿ INFUSION ADAPTER C100J ADMINISTRATION SET LHI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other