BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P53J

    MDR report key: 8794447 · Received July 16, 2019

    Report

    Report Number
    3003152976-2019-00466
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    July 8, 2019
    Report Date
    September 17, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION:INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE SAMPLE, A LEAK WAS OBSERVED BETWEEN THE PROTECTOR AND THE VIAL. IT WAS NOTED THE PROTECTOR WAS FITTED TO THE VIAL AT AN INCLINE, LEAVING AN OPENING BETWEEN THE VIAL AND PROTECTOR. FURTHER TESTING WAS CONDUCTED AND AFTER PROPERLY RECONNECTING THE VIAL AND PROTECTOR USING THE M12 ASSEMBLY FIXTURE, NO SIGN OF LEAKAGE OCCURRED AND LIQUID INSIDE THE SYRINGE COULD MOVE TO VIAL AND BACK TO SYRINGE WITHOUT ISSUE. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1711129. LEAKAGE TESTING IS PERFORMED FOR ALL LOTS DURING MANUFACTURING TO ENSURE THE QUALITY OF THE MEMBRANE. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE PROTECTOR WAS NOT PROPERLY CONNECTED TO THE VIAL WHICH RESULTED IN THE LEAK REPORTED. THE PROTECTOR MUST BE ATTACHED COMPLETELY VERTICAL TO THE VIAL. THE M12 ASSEMBLY FIXTURE IS RECOMMENDED TO EASE THE CONNECTION OF THE PROTECTOR TO THE VIAL. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM. LEAK BETWEEN PROTECTOR AND VIAL ONE SAMPLE WAS EVALUATED BY JFR LAB. ACCORDING TO JFR LAB: NO LEAKAGE INTO BLADDER WAS FOUND THE PROTECTOR WAS FITTED TO VIAL INCLINED. THERE WERE OPENINGS BETWEEN VIAL AND PROTECTOR. NO ANOMALY FOUND AFTER THE VISUAL INSPECTION OF THE MEMBRANE. AFTER A FUNCTION TEST OF BLADDER: THE BLADDER WORKED PROPERLY. LIQUID INSIDE THE SYRINGE COULD MOVE TO VIAL AND MOVE BACK TO SYRINGE WITHOUT ANOMALY. NO LEAKAGE FOUND. AFTER A LEAKAGE TEST: LEAKAGE BETWEEN PROTECTOR AND VIAL FOUND. NO LEAKAGE INTO BLADDER FOUND. PROTECTOR WAS RECONNECTED WITH USING M12, AND NO LEAKAGE BETWEEN PROTECTOR AND VIAL WAS FOUND. NO FM WERE FOUND INSIDE THE VIAL INSPECTION AND TESTS PROTECTOR HOUSINGS ARE MOLDED IN BD SAN AUGUSTINE PLANT. VISUAL INSPECTIONS AND CRITICAL DIMENSIONS FOR PROTECTOR HOUSING PARTS (SNAP FIT DIAMETER AND HIGHNESS OF THE PROTECTOR HOUSING INCLUDED) ARE PERFORMED ACCORDING TO PH-300 CURRENT VERSION. DURING ASSEMBLY PROCESS, THE OPERATOR PERFORMS THE FOLLOWING INSPECTIONS AND TESTS ACCORDING TO PH-302 CURRENT VERSION: IT IS VERIFIED THAT EXPANSION FILM OF THE BLADDER IS CENTERED IN THE PROTECTOR HOUSING, CORRECTLY SEALED AND FREE OF HOLES OR DAMAGES. VISUAL INSPECTION OF THE FILTER IS PERFORMED TO VERIFY THAT IS CENTERED IN THE PROTECTOR CAVITY, WELDED IN A RIGHT POSITION AND FREE OF HOLES BETWEEN THE FILTER AND FILTER COVER. OVERPRESSURE TEST IS PERFORMED TO VERIFY THAT THE EXPANSION FILM OF THE BLADDER CAN RESIST CERTAIN PRESSURE. FILM BREAKAGE TEST: THE EXPANSION FILM OF THE BLADDER MUST BREAK AT MINIMUM PRESSURE (0,8 BAR). IT IS VERIFY IF THE BREAK IS PRODUCED IN THE SEALING AREA OR AT THE FILM. FUNCTIONALITY TEST IS PERFORMED TO ENSURE PROPERLY WORK OF THE PROTECTOR. HYDROPHOBIC FILTER LEAKAGE IS PERFORMED TO VERIFY THAT NO LEAKS ARE PRESENT IN THE FILTER. FOR ALL LOTS, LEAKAGE TEST IS PERFORMED ACCORDING TO (B)(4) TO ENSURE THE QUALITY OF THE MEMBRANE, BEING THE RESULTS FROM LOT 1711129 CONFORM. LEAKAGE BETWEEN PROTECTOR AND VIAL WAS FOUND, HOWEVER, AFTER RECONNECTION WITH VIAL BY M12 NO LEAK WAS FOUND. THAT MEANS THAT THE PROTECTOR WORKS PROPERLY, BUT AT FIRST TIME IT WAS NOT PROPERLY ATTACHED TO THE VIAL. MOREOVER, PICTURES SHOW THAT THE PROTECTOR WAS FITTED TO VIAL INCLINED, THERE WERE OPENINGS BETWEEN VIAL AND PROTECTOR (SEE PICTURE 3 FROM JFRL REPORT BELOW). THEREFORE; A BAD CONNECTION MAY CAUSE THE LEAKAGE. IT IS RECOMMENDED TO CAREFULLY FOLLOW THE INSTRUCTIONS EXPLAINED IN THE IFU. A MISUSE OF THE DEVICE COULD BE ESTABLISHED AS THE ROOT CAUSE OF THE INCIDENCE REPORTED. PROTECTORS MUST BE CONNECTED COMPLETELY VERTICALLY TO THE VIAL TO ENSURE PROPER ATTACHMENT. M12 ASSEMBLY FIXTURE MAKES EASIER THE CONNECTION. NO MORE ACTIONS ARE NEEDED AT THE MOMENT AS A MISUSE OF THE DEVICE BY THE USER COULD BE ESTABLISHED AS THE ROOT CAUSE OF THE INCIDENCE REPORTED. COMPLAINTS TREND IS EVALUATED IN A MONTHLY BASIS VIA QDA METRICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ PROTECTOR P53J A FLUID LEAK WAS NOTED WHEN DRAWING THE FLUID INTO THE SYRINGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CONNECTED CISPLATIN(CHEMO), LEAKAGE OCCURRED WHEN DRAWING THE DRUG BY SYRINGE. HCP THOUGHT INSERTION WASN'T ENOUGH AND PRESSED THE PROTECTOR DEEPER HOWEVER LEAKAGE OCCURRED AGAIN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ PROTECTOR P53J A FLUID LEAK WAS NOTED WHEN DRAWING THE FLUID INTO THE SYRINGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CONNECTED CISPLATIN (CHEMO), LEAKAGE OCCURRED WHEN DRAWING THE DRUG BY SYRINGE. HCP THOUGHT INSERTION WASN'T ENOUGH AND PRESSED THE PROTECTOR DEEPER HOWEVER LEAKAGE OCCURRED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588987 BD PHASEAL¿ PROTECTOR P53J CLOSED DRUG DELIVERY SYSTEM LHI BECTON DICKINSON, S.A. 1711129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other