BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 20337672 · Received September 30, 2024

    Report

    Report Number
    1213809-2024-00680
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 10, 2024
    Report Date
    December 20, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). - SUPPLEMENTAL MDR - LEAKAGE OTHER. THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED. ONE SAMPLE IS OUT OF THE PLASTIC SHIELD AND THE NEEDLE BENT 90 DEGREES ABOUT AT THE MIDDLE. EACH SAMPLE WAS ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. ALL THREE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW WITHOUT ANY LEAKAGE OBSERVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4116101. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL#: 305901, BATCH#: 4116101. IT WAS REPORTED THAT THE BD SAFETY-LOK LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE HAD AN OPPORTUNITY TO SPEAK TO THE NURSE AND THE LEAK DID NOT OCCUR WHERE I WAS INITIALLY TOLD. THE LEAK OCCURRED BETWEEN THE C35-0 CONNECTOR AND THE NEEDLE. PLEASE SEE THE ANSWERS TO YOUR QUESTIONS IN RED LOT NUMBER OF THE INJECTOR USED (I REALIZE YOU MAY NOT HAVE THE INJECTOR THAT WAS USED, BUT CAN YOU GIVE ME A LOT FROM THE BIN IN WHICH YOU TOOK YOU SUPPLY FROM) INJECTOR (N35-0), LOT: 2311304 OR 2308301. CONNECTOR (C35-0), LOT: 2301601 OR LOT: 2308501 OR LOT: 2309506. WHAT BRAND SYRINGE WHERE YOU USING? IF THIS WAS A BD SYRINGE, WHAT IS THE SIZE (SKU) LOT NUMBER AND AGAIN PLEASE KEEP SOME SAMPLES? SYRING IS BD 3ML, LOT: 4142402 OR LOT: 4129704. WAS IT A DROPLET, DROPLETS OR MLS THAT WHERE LEAKING? 2-3 DROPLETS. DID THE PATIENT MISS SOME OF HIS/HER DOSE BECAUSE OF THIS? THE PATIENT DID NOT GET THEIR FULL DOSE. PATIENT GOT APPROX. 1/2 THEIR DOSE. WHAT DRUG WAS THE NURSE EXPOSED TO? BORTEZOMIB. DID THE NURSE CONTINUE TO GIVE THE INFUSION WITH THE LEAKING INJECTOR, OR DID SHE TAKE OFF AND ADD ANOTHER ONE? THE NURSE ATTACHED A C35-0 CONNECTOR TO THE N35-0 INJECTOR, AND THEN A NEEDLE ATTACHING TO C35-05 CONNECTOR. THE LEAK OCCURRED BETWEEN THE NEEDLE AND THE C35-0 CONNECTOR. NEEDLE = BD SAFETYGLIDE 25G X 5/8¿ TW (05MM X 16MM) LOT#: 4116101. I WILL INCLUDE 3 SAMPLES TO SEND TO YOU. THE TWO SKUS INVOLVED IN THIS PIR ARE THE C35-O CONNECTOR 515070 AND THE BD SAFETY GLIDE NEEDLE LISTED BELOW. (THE INJECTOR HAS NOTHING TO DO WITH THIS PIR). YOUR MAIN CONTACT IS XXXXXX. SHE IS HOLDING SAMPLES OF THE SKUS FROM THE SAME LOT USED AND WILL RETURN ONCE YOU PROVIDE A FEDEX LABEL ADDITIONAL INFORMATION PROVIDED: 1. DATE OF OCCURRENCE: TUESDAY ON (B)(6) 2024. 2. NO ADVERSE EVENT REPORTED. 3. MULTIPLE LOTS WERE GIVEN AS WE ARE NOT SURE WHICH LOT EXACTLY WAS USED. I WILL SEND A SAMPLE OF ALL LOTS NOTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40526 BD SAFETY-LOK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4116101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown