BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE NEEDLE

    MDR report key: 10759756 · Received October 29, 2020

    Report

    Report Number
    1213809-2020-00766
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 9, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: ONE PHOTO DISPLAYING THE TOP VIEW OF A SAFETYGLIDE BLISTER PACK FROM BATCH 9150892 (B)(4) WAS RECEIVED AND EVALUATED. PHYSICAL UNUSED SAMPLES FROM THE SAME BATCH ARE NECESSARY FOR A MORE THOROUGH EVALUATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: THE REPORTED DEFECT COULD NOT BE CONFIRMED BASED ON THE PHOTO RECEIVED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES ARE NOT DRAWING UP THE MEDICATION EASILY. IN ADDITION, THE STAFF HAS REPORTED THAT ON TWO OCCASIONS THAT THEY HAVE MET RESISTANCE WHEN TRYING TO ADMINISTER THE MEDICATION TO A PATIENT, CAUSING THE STAFF TO ADMINISTER A NEW VACCINE TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224737 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 9150892 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1