BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PHASEAL¿ INJECTOR

    MDR report key: 8223860 · Received January 7, 2019

    Report

    Report Number
    2243072-2018-01980
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 14, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. A LOT NUMBER WAS NOT PROVIDED FOR THE INJECTOR PRODUCT, HOWEVER, A LOT NUMBER WAS PROVIDED FOR THE CONNECTOR PRODUCT USED WITH THE INJECTOR. A DEVICE HISTORY RECORD REVIEW FOR THE CONNECTOR PRODUCT (LOT 1801107) DID NOT REVEAL ANY DOCUMENTED ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. FOUR RETAINED CONNECTOR SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR INVESTIGATION. INVESTIGATION CONCLUSION: VISUAL INSPECTION OF THE PICTURE REVEALED AN INJECTOR WITH AN EXPOSED CANNULA AND DISLOCATED GRIPS. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS ON THE RETAINED SAMPLES AND FUNCTIONALITY TESTING ALSO DID NOT REVEAL ANY DEFECTS. INJECTOR NEEDLES BECOME EXPOSED IF THEY ARE NOT PROPERLY DISENGAGED, WHICH ALSO RESULTS IN SAFETY SLEEVE BREAKAGE. ROOT CAUSE DESCRIPTION: IT IS IMPORTANT TO HOLD ONTO THE WHITE COMPONENTS OF THE INJECTOR WHEN ENGAGING/DISENGAGING; DO NOT GRIP THE BLUE SAFETY SLEEVE. 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 PULLED IT STRAIGHT BACK AND IT CANNOT BE FORCEFULLY ENGAGED. IT HAS BEEN DETERMINED THAT THIS INCIDENT MOST LIKELY OCCURRED DUE TO IMPROPER USE. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD PHASEAL¿ INJECTOR WAS AN ISSUE WITH FAILURE ON DISCONNECT EXPOSING THE NEEDLE.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD PHASEAL¿ INJECTOR WAS AN ISSUE WITH FAILURE ON DISCONNECT EXPOSING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16101 UNSPECIFIED BD PHASEAL¿ INJECTOR INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other