BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50J

    MDR report key: 7349196 · Received March 19, 2018

    Report

    Report Number
    3003152976-2018-00116
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 28, 2018
    Report Date
    April 4, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINTS REFERS TO LEAKAGE BETWEEN C100 INFUSION ADAPTER AND THE INFUSION BAG. THE SAMPLE HAS BEEN EVALUATED BY JFR LAB. ACCORDING TO ITS REPORT THE LEAK WAS CONFIRMED. NO DEFECTS WERE FOUND IN SPIKE NEEDLE. THE RUBBER STOPPER OF THE INFUSION BAG WAS FOUND DAMAGED. INSPECTIONS IN MANUFACTURING AREA: ALL COMPONENTS OF CONNECTOR C100, EXCEPT THE MEMBRANE, ARE MOLDED IN NOLATO SUPPLIER. AFTER MOLDING, THE COMPONENTS ARE ASSEMBLED IN S. AGUSTIN 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 ON ALL LOTS ACCORDING TO PC-226. CONCLUSION IN THIS CASE THE LEAK WAS CONFIRMED. THE DAMAGE WAS FOUND IN THE RUBBER STOPPER OF THE INFUSION BAG. NO DEFECTS WERE FOUND IN C100 INFUSION ADAPTER. DHR CANNOT BE REVIEWED AS THE LOT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO LOT # PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD PHASEAL¿ PROTECTOR P50J WAS FOUND LEAKING AS ¿WHEN PREPARING OXALIPLATIN (CHEMO), THE MEDICATION LEAKED FROM THE CONNECTION.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194103 BD PHASEAL¿ PROTECTOR P50J ADMINISTRATION SET LHI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other