BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 21154551 · Received January 14, 2025

    Report

    Report Number
    1213809-2024-01056
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 23, 2024
    Report Date
    February 1, 2025
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWENTY-TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 4278415. 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. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE 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

    MATERIAL#: 305916, BATCH#: 4278415. 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 EMAIL. EMAIL(S) ATTACHED. I AM REACHING OUT BECAUSE THE FAIRBURY OFFICE RECENTLY HAD AN ISSUE ADMINISTERING A VACCINE, THEY WERE UNABLE TO "PUSH" THE MEDICATION THROUGH. THEY WERE USING A 25G NEEDLE. WE PULLED THE MEDICATION. IT WAS ALSO BROUGHT TO OUR ATTENTION THAT SOME SITES HAVE BEEN HAVING ISSUES WITH NEEDLES AND THEREFOR I WANTED TO PASS ALONG THE INFORMATION BELOW IN THE EVENT IT WAS RELATED. I WILL SAY THAT AFTER DISCUSSING WITH THE NURSES THEY DO NOT FEEL THIS IS A NEEDLE ISSUE BECAUSE THEY ARE ABLE TO USE THESE NEEDLES WITH OTHER MEDICATIONS JUST FINE. ADDITIONALLY, WHEN ATTEMPTING TO ADMINISTER THIS SPECIFIC MEDICATION, THEY ALSO TRIED A 23 G NEEDLE AND HAD THE SAME ISSUE, "UNABLE TO PUSH" THE MEDICATION. HAS BD GIVEN YOU ANY GUIDANCE ON ISSUES OR THE CONTINUED USE OF THESE NEEDLES? LOT: 4278415, EXPIRATION: 9/30/2029, REF 305916, BD SAFETYGLIDE INJECTION NEEDLE 25GX1." ADDITIONAL INFORMATION PROVIDED: 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE WHETHER YOU ARE FACING CLOGGED IN THE NEEDLE OR PLUNGER MOVEMENT DIFFICULTY. PLUNGER MOVEMENT DIFFICULTY. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. REPEAT STICKS. 3. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 23-012-2024. 4. TOTAL NUMBER OF OCCURRENCES? X2. 5. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO PHOTO, PULLED BOX FROM STOCK. (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988296 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4278415 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown