BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15791960 · Received November 14, 2022

    Report

    Report Number
    1213809-2022-00962
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 12, 2022
    Report Date
    October 24, 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2003405; MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026; DEVICE MANUFACTURE DATE: 03-JAN-2022; MEDICAL DEVICE LOT #: 2003406; MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026; DEVICE MANUFACTURE DATE: 03-JAN-2022. INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE NEEDLES WERE CLOGGED. TO AID IN THE INVESTIGATION, THIRTY-NINE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. TWENTY 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. EIGHTEEN SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. TWO SAMPLES DID NOT EXPEL THE SOLUTION; THESE NEEDLES ARE CLOGGED. BASED ON THE QUALITY TEAM¿S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CLOGGED NEEDLE CAN BE TRACED TO THE MANUFACTURING PROCESS. DURING REVIEW OF THE PROCESS, 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. FURTHERMORE, 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 IS CONFIRMED. 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 1 BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 2003405 AND 2003406 EXPERIENCED BLOCKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "4 OF MY KP SITES IN _______ ARE ALL EXPERIENCING PROBLEMS WITH BD 25GX1" NEEDLES RESULTING IN BLOCKAGE... THE ISSUES HAVE CERTAINLY NOT BEEN RESOLVED AND CONTINUE TO GROW. WITH FLU SEASON IN FULL SWING, THIS IS IMPACTING CLINICS... 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
    351483 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown