BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17912123 · Received October 11, 2023

    Report

    Report Number
    1213809-2023-01124
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 18, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)¿ FOLLOW UP MDR FOR DEVICE EVALUATION IT WAS REPORTED THE PRODUCT WOULD NOT ADVANCE THROUGH THE NEEDLE. TO AID IN THE INVESTIGATION, SIX HUNDRED THIRTY SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHTY SAMPLES WERE RANDOMLY SELECTED. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. SEVENTY-NINE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. ONE SAMPLE DID NOT EXPEL THE SOLUTION; THIS NEEDLE IS CLOGGED. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOT 2202914. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2202914 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCHES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO ENSURE THE NEEDLE LUBRICATION IS APPLIED APPROPRIATELY. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD IS 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. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED 10 OF THE BD SAFETYGLIDE¿ NEEDLE ARE BLOCKED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PLUNGER ON SYRINGE WILL NOT DEPLOY. CUSTOMER BOUGHT 2 CASES W THIS LOT NUMBER AND HAS ONLY TRIED ITEMS FROM ONE CASE BUT WANTS TO RETURN BOTH BECAUSE OF AN ABUNDANCE OF CAUTION AS IT IS AN INCONVENIENCE FOR THESE NOT TO WORK WHEN THEY ARE ADMINISTERING VACCINES. CUSTOMER UPDATE (B)(6) 2023. THE PRODUCT WON¿T ADVANCE THROUGH THE DEFECTIVE NEEDLES, INCLUDING AIR, SO WE WERE UNABLE TO PRIME VACCINES. WE CHANGED THE NEEDLE OUT WHENEVER THEY DIDN¿T PRIME AND USED A NEW NEEDLE BEFORE ADMINISTERING THE VACCINE. NO MEDICAL INTERVENTION WAS NEEDED AND NO ADVERSE EVENTS WERE EXPERIENCED FOR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180410 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2202914 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown