BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 12407189 · Received September 1, 2021

    Report

    Report Number
    3003152976-2021-00536
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    July 29, 2021
    Report Date
    September 21, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO RECEIVED FOR INVESTIGATION, ONE OPTIMA INJECTOR HUB CONNECTED TO A SYRINGE WITH THE NEEDLE EXPOSED WAS OBSERVED. FIFTEEN RETAINED SAMPLES FROM THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. NO DAMAGE OR OTHER DEFECTS WAS OBSERVED ON ANY OF THE PRODUCT. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR TO A SAMPLE SYRINGE, PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. EACH SAMPLE WAS TESTED TEN TIMES AND EACH TIME THERE WERE NO ISSUES OBSERVED WITH THE SYRINGES AND THE INJECTOR. ISSUE OBSERVED BY THE CUSTOMER (LUER LOCK BREAKAGE) COULD NOT BE REPLICATED ON NONE OF RETAINED SAMPLES AND THEREFORE THE EVENT REPORTED COULD NOT BE CONFIRMED. MOREOVER, A SHORT-TERM LEAKAGE TEST WAS PERFORMED ON INJECTOR FOR 30 SAMPLES, NO ISSUES WERE FOUND THAT COULD BE INVOLVED IN THE INCIDENCE REPORTED. NO LUER LOCK BREAKAGE NOR BROKEN INJECTOR SAFETY SLEEVE WAS NOTICED. IN ALL CASES, THE PRODUCT FUNCTIONED PROPERLY AND THERE WERE NO ISSUES OBSERVED BETWEEN THE CONNECTION OF THE INJECTORS AND PROTECTOR. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2101309, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE BECAME EXPOSED WHEN THE OUTER MEMBRANE OF THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) STUCK TO THE PROTECTOR DURING DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE COMPOUNDING A HAZARDOUS DRUG, THE MEMBRANE AND OUTER LAYER OF THE OPTIMA INJECTOR (N35-O) STUCK TO THE VIAL PROTECTOR AND EXPOSED THE NEEDLE."

    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 THE NEEDLE BECAME EXPOSED WHEN THE OUTER MEMBRANE OF THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) STUCK TO THE PROTECTOR DURING DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE COMPOUNDING A HAZARDOUS DRUG, THE MEMBRANE AND OUTER LAYER OF THE OPTIMA INJECTOR (N35-O) STUCK TO THE VIAL PROTECTOR AND EXPOSED THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301400 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2101309

    Patients

    Seq Age Sex Outcome Treatment
    1