BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35C

    MDR report key: 7659491 · Received July 3, 2018

    Report

    Report Number
    3003152976-2018-00279
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    May 29, 2018
    Report Date
    August 16, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150044
    PMA / PMN Number
    K140591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT NUMBER 1802103 WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER, NO SAMPLES OR PICTURE SAMPLES WERE PROVIDED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION OF LOT 1802103 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ONE RETAINED SAMPLE OF THE SAME LOT NUMBER WAS OBTAINED FROM THE MANUFACTURING FACILITY FOR INVESTIGATION. UPON INSPECTION AND FUNCTIONALITY TESTING, NO ISSUES WERE FOUND WITH THE RETAINED INJECTOR SAMPLE. NEEDLE EXPOSURE RESULTS WHEN THE SAFETY SLEEVE IS BROKEN. SAFETY SLEEVE BREAKAGE OCCURS WHEN THE INJECTOR IS NOT PROPERLY ENGAGED/DISENGAGED. WHEN ENGAGING AND DISENGAGING THE INJECTOR IT IS IMPORTANT TO HOLD ONTO THE WHITE COMPONENTS, DO NOT TOUCH THE BLUE SLEEVE. IF THE GRIPS OF THE BLUE SAFETY SLEEVE ARE DISLOCATED, THE INJECTOR IS ACTIVATED AND THE CANNULA BECOMES EXPOSED. THE INJECTOR MUST BE REMOVED BY PULLING IT STRAIGHT BACK; IF THIS TECHNIQUE IS NOT PERFORMED, THE GRIPS ARE REMOVED FROM THEIR PLACE AND CANNULA EXPOSURE OCCURS. IF THE INJECTOR HAS BEEN FORCED WHILE ENGAGING, THE GRIPS MAY ALSO BECOME DAMAGED. THE TESTS PERFORMED DURING THE MANUFACTURING PROCESS TO AVOID FAULTY PARTS ARE LISTED BELOW: DURING MOLDING PROCESS: VISUAL INSPECTIONS FOR INJECTOR PARTS (CYLINDER, NEEDLE HOUSING, SAFETY SLEEVE, PISTON AND MEMBRANE) ARE PERFORMED BY THE OPERATOR TO AVOID FAULTY PARTS (FLASHES, UNFILLED AND BURNED PARTS, ETC). CRITICAL TO QUALITY DIMENSIONS OF ALL INJECTOR COMPONENTS ARE MEASURED TO CHECK IF THE DIMENSIONS ARE WITHIN TOLERANCE. THE FOLLOWING VISUAL INSPECTIONS ARE PERFORMED BY THE OPERATOR DURING THE ASSEMBLY PROCESS: - SAFETY SLEEVE MUST BE CONNECTED AND SHOULD BE TURNING WITH THE CYLINDER AND PISTON. THE FUNCTIONALITY OF THE GRIPS IS VERIFIED. VERIFY THE CORRECT WELDING OF THE MEMBRANE, COLOR AND ASPECT. CYLINDER ASSEMBLY. PISTON MUST BE FIXED BY THE SAFETY SLEEVE. NEEDLE HOUSING SHOULD ROTATE CLOCKWISE AND TIP OF THE CANNULA MUST BE OBSERVED. CANNULA LENGTH (WITH A CALLIPER GAUGE). FUNCTIONALITY AND PISTON WELDING TEST: QUALITY AND FUNCTIONALITY OF THE MEMBRANE IS VERIFIED AFTER BE WELDING AND PENETRATED BY THE CANNULA. CONCLUSION: THE EXPOSURE OF THE NEEDLE IS CAUSED DUE TO THE BREAKAGE OF THE SAFETY SLEEVE. THE BREAKAGE OCCURS WHEN THE INJECTOR IS NOT PROPERLY DISENGAGED. IT WAS DETERMINED THAT NO CAPA IS REQUIRED.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INJECTOR SPLIT APART ON A BD PHASEAL¿ INJECTOR LUER LOCK N35C, EXPOSING THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INJECTOR SPLIT APART ON A BD PHASEAL INJECTOR LUER LOCK N35C, EXPOSING THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 INJECTOR SPLIT APART ON A BD PHASEAL¿ INJECTOR LUER LOCK N35C, EXPOSING THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499977 BD PHASEAL¿ INJECTOR LUER LOCK N35C INJECTOR ONB BECTON DICKINSON, S.A. 1802103 30382905150044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other