BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G

    MDR report key: 17761509 · Received September 15, 2023

    Report

    Report Number
    1213809-2023-01026
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 24, 2023
    Report Date
    October 5, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    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

    H6: INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. 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. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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: 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 USING THE BD SAFETYGLIDE NEEDLE 25 G BY 1 INCH TODAY, I ENCOUNTERED RESISTANCE WHEN TRYING TO EXPEL THE AIR AND FILL THE NEEDLE WITH THE VACCINE. THE RESISTANCE WAS SIGNIFICANT ENOUGH THAT I WAS CONCERNED THE PRESSURE WOULD FORCE THE NEEDLE OFF THE BARREL. I CHOSE TO REPLACE THE NEEDLE INSTEAD WITH A 1" NEEDLE FROM A DIFFERENT LOT NUMBER.

    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: 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 USING THE BD SAFETYGLIDE NEEDLE 25 G BY 1 INCH TODAY, I ENCOUNTERED RESISTANCE WHEN TRYING TO EXPEL THE AIR AND FILL THE NEEDLE WITH THE VACCINE. THE RESISTANCE WAS SIGNIFICANT ENOUGH THAT I WAS CONCERNED THE PRESSURE WOULD FORCE THE NEEDLE OFF THE BARREL. I CHOSE TO REPLACE THE NEEDLE INSTEAD WITH A 1" NEEDLE FROM A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294955 BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2007149 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown