BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 20034300 · Received August 22, 2024

    Report

    Report Number
    1213809-2024-00575
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATION: FIVE HUNDRED AND FIVE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE HUNDRED AND TWENTY-EIGHT SAMPLE WERE RANDOMLY SELECTED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ONE HUNDRED AND NINETEEN SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW, EIGHT SAMPLES FROM LOT 2024137 AND ONE SAMPLE FROM LOT 2007149 DID NOT EXPEL THE SOLUTION; THESE NEEDLES ARE CLOGGED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 2024137, 1112721, 2007149 AND 1152501. 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. BASED ON THE INVESTIGATION AND WITH THE 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 THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. FAILURE MODE: CLOGGED/BLOCKED. LABEL CASE 25X1 SG CE 305916 DG1310-06. PRODUCTCOMPLAINT YES, 5 BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29677 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 1152501 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown