BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 18641373 · Received February 5, 2024

    Report

    Report Number
    1213809-2024-00058
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 2, 2024
    Report Date
    March 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP REPORT FOR CORRECTION. THE DATE RECEIVED BY MANUFACTURER WAS INCORRECT IN THE INITIAL MDR. THE CORRECT DATE IS 02-JAN-2024.

    Additional Manufacturer Narrative · 0

    PR 9481043 ¿ FOLLOW UP MDR FOR DEVICE EVALUATION 88 SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. 50 SAMPLES WERE RANDOMLY SELECTED. VISUAL INSPECTION WAS PERFORMED. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2202913. 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 WAS NOT 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: "SOME NEEDLES THAT ARE DEFECTIVE AND DON¿T ALLOW FOR INJECTION." LOT#: 2202913.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792530 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMF BECTON DICKINSON MEDICAL SYSTEMS 2202913 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown