BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 8894833 · Received August 14, 2019

    Report

    Report Number
    3003152976-2019-00538
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K140591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1903110, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAMPLE LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DAMAGED WAS IDENTIFIED. THE INJECTOR WAS THEN CONNECTED TO A SYRINGE, PROTECTOR, AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE INJECTOR WAS DISASSEMBLED, NO DEFECTS OBSERVED WITHIN THE CANNULA. IF THE GRIPS OF THE SAFETY SLEEVE BECOME DISLOCATED, THE INJECTOR IS ACTIVATED CAUSING NEEDLE EXPOSURE. TO AVOID DAMAGE TO THE SAFETY SLEEVE GRIPS, THE INJECTOR MUST BE REMOVED BY PULLING IT STRAIGHT BACK AND IT CANNOT BE FORCEFULLY ENGAGED. THE INSTRUCTIONS FOR USE MUST BE CAREFULLY FOLLOWED WHEN USING THE PHASEAL DEVICES IN ORDER TO AVOID ANY DAMAGE TO THE PRODUCT THAT MAY RESULT IN THE DEVICE NOT FUNCTIONING AS INTENDED. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. THE DEFECT COULDN¿T BE REPRODUCED USING THE RETAINED SAMPLES: THE BREAKAGE OF THE SAFETY SLEEVE OCCURS WHEN THE INJECTOR IS NOT PROPERLY DISENGAGED, DUE TO A BAD HANDLING OF THE DEVICE. IT IS IMPORTANT TO HOLD ONTO THE WHITE PART OF THE INJECTOR BEFORE ENGAGING/DISENGAGING. DO NO TOUCH THE BLUE PART: IF GRIPS OF THE SAFETY SLEEVE ARE REMOVED FROM THEIR PLACE, THE INJECTOR IS ACTIVATED CAUSING NEEDLE EXPOSURE. THE INJECTOR MUST BE REMOVED PULLING IT BACK: IF IT IS REMOVED WITHOUT DOING THIS THE GRIPS ARE REMOVED FROM THEIR PLACE AND NEEDLE EXPOSURE HAPPENS. IF THE INJECTOR HAS BEEN FORCED WHILE ENGAGING, THE GRIPS CAN ALSO GET DAMAGED. SINCE THE DESCRIPTION OF THE INCIDENT STATES THAT THE TECHNICIAN WAS TURNING THE N35 THE WRONG WAY AND RESULTED WITH A NEEDLE EXPOSURE, A MISUSE OF THE DEVICE COULD BE ESTABLISHED AS THE ROOT CAUSE OF THIS COMPLAINT. BREAKAGE OF THE INJECTOR IS EVALUATED UNDER CAPA 708467. NO MORE CORRECTIONS ARE NEEDED AS A MISUSE OF THE DEVICE CAN BE ESTABLISHED AS THE ROOT CAUSE OF THE INCIDENCE REPORTED.

    Additional Manufacturer Narrative · 0

    THE CHANGES ARE AS FOLLOWS: G.2 MANUFACTURING LOCATION: BECTON DICKINSON, S.A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "RX TECH WAS USING N35 & P50 TO PREP CHEMO. RX TECH WAS ATTEMPTING TO DETACH THE N35 FROM THE P50 AFTER WITHDRAWING DRUG FROM THE VIAL AND HAD A NEEDLE EXPOSURE. MET WITH RX TECH AND DISCOVERED RX TECH WAS TURNING THE N35 THE WRONG WAY AND RESULTED WITH A NEEDLE EXPOSURE. REINFORCED CORRECT CONNECTION AND DISCONNECTION OF N35 WITH RETURN DEMONSTRATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "RX TECH WAS USING N35 & P50 TO PREP CHEMO. RX TECH WAS ATTEMPTING TO DETACH THE N35 FROM THE P50 AFTER WITHDRAWING DRUG FROM THE VIAL AND HAD A NEEDLE EXPOSURE. MET WITH RX TECH AND DISCOVERED RX TECH WAS TURNING THE N35 THE WRONG WAY AND RESULTED WITH A NEEDLE EXPOSURE. REINFORCED CORRECT CONNECTION AND DISCONNECTION OF N35 WITH RETURN DEMONSTRATION."

    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 SEPARATION OCCURRED DURING USE WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "RX TECH WAS USING N35 & P50 TO PREP CHEMO. RX TECH WAS ATTEMPTING TO DETACH THE N35 FROM THE P50 AFTER WITHDRAWING DRUG FROM THE VIAL AND HAD A NEEDLE EXPOSURE. MET WITH RX TECH AND DISCOVERED RX TECH WAS TURNING THE N35 THE WRONG WAY AND RESULTED WITH A NEEDLE EXPOSURE. REINFORCED CORRECT CONNECTION AND DISCONNECTION OF N35 WITH RETURN DEMONSTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689364 BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1903110 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other