BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES

    MDR report key: 17299039 · Received July 11, 2023

    Report

    Report Number
    1213809-2023-00721
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 16, 2023
    Report Date
    July 13, 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
    PA, 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. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2087382. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. H.4. DEVICE MANUFACTURE DATE: 28-MAR-2022. D.4. MEDICAL DEVICE LOT #: 2188472. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H.4. DEVICE MANUFACTURE DATE: 07-JUL-2022. D.4. MEDICAL DEVICE LOT #: 2202914. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H.4. DEVICE MANUFACTURE DATE: 21-JUL-2022. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. THE SAMPLE DID NOT EXPEL THE SOLUTION; THIS NEEDLE IS CLOGGED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 3 LOTS OF MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES THE NEEDLES WERE CLOGGED. THIS OCCURRED WITH 1 NEEDLE FROM LOT# 2087382, 7 FROM LOT# 2188472, AND 3 FROM LOT# 2202914. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLOGGED NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 3 LOTS OF MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES THE NEEDLES WERE CLOGGED. THIS OCCURRED WITH 1 NEEDLE FROM LOT# 2087382, 7 FROM LOT# 2188472, AND 3 FROM LOT# 2202914. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLOGGED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569397 MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 306616 SEE H.10 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown