BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 16936108 · Received May 15, 2023

    Report

    Report Number
    3003152976-2023-00178
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    January 20, 2023
    Report Date
    July 21, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150036
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, INJECTOR IS DISPLAYED WITH A DROP OF LIQUID ON THE SIDE, UNABLE TO CONFIRM FAILURE BASED ON IMAGES. PHYSICAL SAMPLES ARE NECESSARY TO FURTHER ANALYZE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2210002, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR ALONG WITH A SAMPLE PROTECTOR TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. DURING MANUFACTURING, LEAKAGE TESTING IS PERFORMED, PENETRATING THE INJECTOR TEN TIMES TO VERIFY IF ANY LEAKS OCCUR. TESTING WAS REVIEWED FOR INJECTOR LOT 2210002, RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. PRODUCT UNDERGOES A SERIES OF TESTING DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. THESE TESTS INCLUDE VISUAL INSPECTIONS ALONG WITH LEAKAGE TESTING AND FLOW RATE, ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT 4 BD PHASEAL¿ INJECTORS LUER LOCK N35 LEAKED THROUGH PRE-EXISTING LITTLE HOLES IN THE WHITE PART OF THE INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE USE OF PHASEAL SYSTEM IN THE CHEMOTHERAPY DEPARTMENT OF XXXXX THERE ARE 4 INCIDENTS OF LEAKAGE OF THE DRUG THROUGH THE LITTLE HOLES THAT EXIST IN THE WHITE PART OF PHASEAL INJECTOR. THE USER IS SURE THAT THE LEAKAGE DID NOT COME THROUGH THE LUER LOCK CONNECTION BETWEEN THE SYRINGE AND THE INJECTOR. THE CLIENT USES THE SYSTEM FOR 5 YEARS NOW, AND IT¿S THE FIRST TIME THEY REPORT SUCH AN INCIDENT. HOW OFTEN HAS THE DEFECT OCCURRED? 4 WHEN DID THE INCIDENT OCCUR? DURING USE DEATH? NO SERIOUS INJURY NO ERRONEOUS RESULTS NO COURSE OF TREATMENT CHANGED DUE TO EVENT NO EXPOSURE TO BLOOD/BODILY FLUID MEDICAL INT. OTHER THAN FIRST AID NO NEEDLE/PROBE STICK NO SAFETY ISSUE NO OTHER ACTIONS TAKEN -THE USER CLEANED THE AREA IN THE HOOD, AND CHANGED GLOVES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PHASEAL¿ INJECTORS LUER LOCK N35 LEAKED THROUGH PRE-EXISTING LITTLE HOLES IN THE WHITE PART OF THE INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE USE OF PHASEAL SYSTEM IN THE CHEMOTHERAPY DEPARTMENT OF XXXXX THERE ARE 4 INCIDENTS OF LEAKAGE OF THE DRUG THROUGH THE LITTLE HOLES THAT EXIST IN THE WHITE PART OF PHASEAL INJECTOR. THE USER IS SURE THAT THE LEAKAGE DID NOT COME THROUGH THE LUER LOCK CONNECTION BETWEEN THE SYRINGE AND THE INJECTOR. THE CLIENT USES THE SYSTEM FOR 5 YEARS NOW, AND IT¿S THE FIRST TIME THEY REPORT SUCH AN INCIDENT. HOW OFTEN HAS THE DEFECT OCCURRED?: 4 WHEN DID THE INCIDENT OCCUR? DURING USE DEATH?: NO. SERIOUS INJURY: NO. ERRONEOUS RESULTS: NO. COURSE OF TREATMENT CHANGED DUE TO EVENT: NO. EXPOSURE TO BLOOD/BODILY FLUID MEDICAL INT. OTHER THAN FIRST AID, NO. NEEDLE/PROBE STICK: NO . SAFETY ISSUE; NO. OTHER ACTIONS TAKEN -THE USER CLEANED THE AREA IN THE HOOD, AND CHANGED GLOVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575007 BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515003 2210002 00382905150036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown