BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES

    MDR report key: 17444549 · Received August 2, 2023

    Report

    Report Number
    1213809-2023-00799
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 9, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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 · 0

    IT WAS REPORTED THAT DURING USE WITH MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES THE NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER STATES A CUSTOMER IS USING SAFETY HYPODERMIC NEEDLE 306616 AND NOTICING THAT THEY CAN DRAW UP SOLUTION BUT CANNOT EXPEL THE SOLUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES THE NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER STATES A CUSTOMER IS USING SAFETY HYPODERMIC NEEDLE 306616 AND NOTICING THAT THEY CAN DRAW UP SOLUTION BUT CANNOT EXPEL THE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695473 MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown