BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 18253532 · Received December 3, 2023

    Report

    Report Number
    1213809-2023-01374
    Event Type
    Malfunction
    Date Received
    December 3, 2023
    Date of Event
    November 8, 2023
    Report Date
    February 12, 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
    IL, 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. 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

    PR 9220567- FOLLOW UP MDR FOR DEVICE EVALUATION. NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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.

    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: "DEPARTMENT STATES NEEDLE FEELS DULL WHEN ADMINISTERING INTO THE MUSCLE, ALSO COMPLAINTS OF FORCING FLUID INTO THE MUSCLE WITH GREAT RESISTANCE." LOT NUMBER:2024137. DATE OF EVENT:. HOW MANY OCCURRENCES OF THIS NEEDLE DULL HAPPENED? COMPLAINED OF NOT BEING ABLE TO INJECT THE FLUID FROM THE NEEDLE. HOW MANY OCCURRENCES OF HAVING GREAT RESISTANCE WHEN FORCING FLUID INTO THE MUSCLE WITH THIS NEEDLE? MAJORITY OF THE NEEDLES IN THE BOX. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? REPEAT THE INJECTION BY SWITCHING OUT THE NEEDLE. WHAT WAS THE PATIENT OUTCOME? AS STATED ABOVE. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? WHAT PROCEDURE WAS BEING PERFORMED? VACCINATION. WHAT MEDICATION WAS USED IN THE PROCEDURE? VACCINE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504290 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2024137 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown