BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G

    MDR report key: 16653066 · Received March 30, 2023

    Report

    Report Number
    1213809-2023-00294
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 13, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR 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. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: ON (B)(6) 2023. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES. INCIDENT DETAILS: WHEN ATTACHING THE NEEDLES TO THE PREFILLED SYRINGES, THE NEEDLES SEEM TO BE BLOCKED SOMEHOW AND UNABLE TO MOVE AIR OR LIQUID THROUGH. THIS MAKES IM IMPOSSIBLE TO CLEAR THE AIR FROM THE SYRINGE OR SAFELY ADMINISTER THE VACCINE. WHO WAS AFFECTED? NO PERSON AFFECTED. FREQUENCY OF PROBLEM: RECURRING. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY 25GA X 1 IN. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 305916. SERIAL OR LOT NUMBER: UNKNOWN. DEVICE EXPIRY DATE (YYYY-MM-DD): UNKNOWN. SUPPLIER CATALOGUE NUMBER: 308-305916. WAS THE DEVICE RETAINED? NO. EXPECTED TYPE OF INVESTIGATION: REPORT HISTORY/TREND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580974 BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2024137 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown