BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17927401 · Received October 12, 2023

    Report

    Report Number
    1213809-2023-01135
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 28, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FURTHERMORE, 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. 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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

    MATERIAL #: 306616. BATCH #: 2202914. IT WAS REPORTED BY CUSTOMER THAT THERE IS AN OBSTRUCTION IN SOME OF THE NEEDLES THE MEDICATION WILL NOT GO THROUGH THE NEEDLE, AND THEY CANNOT CLEAR THE BUBBLE FROM THE SYRINGE IT WILL GO THROUGH THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER. DM-23-0916. REPORT DATE 09.28.23. FACTORY/MANUFACTURER. BD MFR REORDER # 192-N251S. PRODUCT NAME. NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT / SERIAL NUMBER (B)(6). PRODUCT CONCERN. THERE IS AN OBSTRUCTION IN SOME OF THE NEEDLES THE MEDICATION WILL NOT GO THROUGH THE NEEDLE AND THEY CANNOT CLEAR THE BUBBLE FROM THE SYRINGE IT WILL GO THROUGH THE NEEDLE. CUSTOMER NAME XXXX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED AND HAD AIR BUBBLES. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PRODUCT CONCERN THERE IS AN OBSTRUCTION IN SOME OF THE NEEDLES THE MEDICATION WILL NOT GO THROUGH THE NEEDLE AND THEY CANNOT CLEAR THE BUBBLE FROM THE SYRINGE IT WILL GO THROUGH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749066 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2202914 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown