BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P14J

    MDR report key: 8837290 · Received July 29, 2019

    Report

    Report Number
    3003152976-2019-00485
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 12, 2019
    Report Date
    September 25, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    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 SUMMARY: TWO SAMPLES OF AN UNKNOWN LOT WERE RECEIVED FOR EVALUATION BY OUR QUALITY PERSONNEL. UPON INSPECTION OF THE SAMPLES, A LEAK WAS OBSERVED BETWEEN THE PROTECTOR AND THE VIAL. IT WAS NOTED THAT THE CANNULA OF THE PROTECTORS HAD PENETRATED THE STOPPER OFF CENTER. 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 DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. TWO SAMPLES WERE EVALUATED BY JFR LAB. ACCORDING TO JFR LAB: NO LEAKAGE INTO BLADDER FOUND FOR BOTH SAMPLES THE PROTECTOR WAS FITTED TO VIAL PROPERLY FOR BOTH SAMPLES. THE NEEDLE PENETRATED OUT OF CENTER OF THE RUBBER STOPPER FOR SAMPLE #1. NO ANOMALY FOUND AFTER THE VISUAL INSPECTION OF THE MEMBRANE FOR BOTH SAMPLES. AFTER A FUNCTION TEST OF BLADDER: FOR SAMPLE#1, THE BLADDER DIDN¿T WORK AT ALL. LIQUID INSIDE THE SYRINGE COULD MOVE TO VIAL AND MOVE BACK TO SYRINGE WITHOUT ANOMALY. NO LEAKAGE INTO BLADDER FOUND. LEAKAGE BETWEEN PROTECTOR AND VIAL WAS FOUND. FOR SAMPLE#2, THE BLADDER WORKED PROPERLY. LIQUID INSIDE THE SYRINGE COULD MOVE TO VIAL AND MOVE BACK TO SYRINGE WITHOUT ANOMALY. NO LEAKAGE FOUND. EEDLE ON N35 PENETRATED THE RUBBER STOPPER OF VIAL PROPERLY FOR BOTH SAMPLES. AFTER A LEAKAGE TEST, FOR BOTH SAMPLES NO LEAKAGE INTO BLADDER FOUND BUT LEAKAGE BETWEEN PROTECTOR AND VIAL WAS FOUND. FOR SAMPLE#1, THE NEEDLE WAS INCLINED FROM THE ROOT. FOR SAMPLE#2, THE NEEDLE WAS DETACHED FROM PROTECTOR. FOR BOTH SAMPLES, IT SEEMS THE NEEDLE ON PROTECTOR PENETRATED THE RUBBER STOPPER OUT OF CENTER. FOR SAMPLE#1, FM WAS FOUND INSIDE THE VIAL. FM IS GRAY IN COLOR AND HAS ELASTICITY. NO FMS WERE FOUND INSIDE THE VIAL FOR SAMPLE #2. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD PHASEAL¿ PROTECTOR P14J HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CONNECTED TO THE VIAL AND HCP TRIED TO DRAW KEYTRUDA (CHEMO) HOWEVER S/HE COULD NOT. THEN HCP KEPT DRAWING AND DRUG LEAKED FROM THE OPENING OF THE PROTECTOR AND THE VIAL. HCP DID NOT USE ASSEMBLY FIXTURE. 2 SAMPLES WILL BE RETURNED. ACTUAL SAMPLE IS ONE OF THEM.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD PHASEAL¿ PROTECTOR P14J HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CONNECTED TO THE VIAL AND HCP TRIED TO DRAW KEYTRUDA (CHEMO) HOWEVER S/HE COULDN'T. THEN HCP KEPT DRAWING AND DRUG LEAKED FROM THE OPENING OF THE PROTECTOR AND THE VIAL. HCP DIDN'T USE ASSEMBLY FIXTURE. 2 SAMPLES WILL BE RETURNED. ACTUAL SAMPLE IS ONE OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630891 BD PHASEAL¿ PROTECTOR P14J PHASEAL ADMINISTRATION SET FPA BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other