BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15761237 · Received November 9, 2022

    Report

    Report Number
    1213809-2022-00925
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 12, 2022
    Report Date
    December 22, 2022
    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, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE NEEDLES WERE CLOGGED. TO AID IN THE INVESTIGATION, SIX THOUSAND AND FIVE HUNDRED SAMPLES FROM LOT 2003405 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NO SAMPLES WERE RETURNED FROM LOT NUMBER 2003406. ONE HUNDRED TWENTY FIVE SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2003405 AND 2003406. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS BLOCKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿BLOCKAGE ISSUES... RESULTING IN NOT HAVING TO POKE A PATIENT TWICE AND NOT REQUIRING EXCESSIVE FORCE FOR THE NURSES (AT THE RISK OF BREAKING THE NEEDLE). NURSES HAVE EXPELLED AIR AND A LITTLE FLUID; EITHER THE SYRINGE IS REALLY HARD TO DEPRESS OR DOES NOT DEPRESS.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS BLOCKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿BLOCKAGE ISSUES... RESULTING IN NOT HAVING TO POKE A PATIENT TWICE AND NOT REQUIRING EXCESSIVE FORCE FOR THE NURSES (AT THE RISK OF BREAKING THE NEEDLE)... NURSES HAVE EXPELLED AIR AND A LITTLE FLUID; EITHER THE SYRINGE IS REALLY HARD TO DEPRESS OR DOES NOT DEPRESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2952265 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2003405 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown