BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 18007594 · Received October 25, 2023

    Report

    Report Number
    1213809-2023-01175
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 15, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    TWO HUNDRED AND TWENTY-TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THEY CAME IN SEALED PACKAGING BLISTERS. VISUAL INSPECTION WAS PERFORMED. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. THEY ALL EXPEL THE SOLUTION WITH NORMAL FLOW. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR EACH POTENTIAL BATCH NUMBER THAT WAS RECEIVED (2202913, 2172849, 2153548, 1209919, 2241654, 2094921, 2202914, 0141234, 2094923, 2087382). ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THE BATCHES WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH LOT OF NEEDLES USED IN THE MANUFACTURING OF THESE BATCHES. DURING THE HISTORY REVIEW, ONE LOT WAS IDENTIFIED AS HAVING SUFFERED FROM CLOGGED NEEDLES DUE TO SILICONE. IT COULD BE POSSIBLE THAT SOME SAMPLES ARE ESCAPES FROM THE INCIDENT THAT OCCURRED DURING PRODUCTION. 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 COULD NOT BE CONFIRMED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 NEEDLES WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED WHEN PUSHING SYRINGES THE NEEDLES FEEL BLOCKED."

    Description of Event or Problem · 0

    SAMPLES OF MULTIPLE POTENTIAL LOT NUMBERS WERE RECEIVED (CUSTOMER CONFIRMED THEY RETURNED WHAT THEY HAD BECAUSE THEY WERE NOT SURE WHAT LOTS WERE NOT WORKING). POTENTIAL LOT NUMBERS RECEIVED: 2202913, 2172849, 2153548, 1209919, 2241654, 2094921, 2202914, 0141234, 2094923, 2087382.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433188 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown