BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO EDGE 3ML NEEDLE W/ SYRINGE

    MDR report key: 20640916 · Received November 8, 2024

    Report

    Report Number
    1217052-2024-00179
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 14, 2024
    Report Date
    March 4, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    UDI-DI
    00351688071029
    PMA / PMN Number
    K071785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVALUATION CODES UPDATED. DEVICE EVALUATION: 22 SAMPLES WERE RECEIVED FOR INVESTIGATION. THE LOT NUMBERS AND QUANTITIES ARE AS FOLLOWS: FOURTEEN UNOPENED SAMPLES OF LOT # 4136814, THREE SEALED PACKAGES OF LOT # 4141025 AND FIVE SAMPLES IN A BAG WITH THE TYVEK MATERIAL IDENTIFYING THE PRODUCT AS LOT # 4141025. SAMPLES OF THE LOT NUMBER REFERENCED BY THE CUSTOMER COMPLAINT FORM WERE NOT RETURNED. VISUAL INSPECTION OF THE PROVIDED PRODUCT FOUND THAT ONE IN THE OPENED BAG HAD A BROKEN PLUNGER. ALL REMAINING RETUNED PRODUCT (21) DID NOT HAVE ANY DEFECTS OR NOTED ANOMALIES. DURING THE FUNCTIONAL TESTING OF THE SAMPLES, LEAKAGE WAS OBSERVED AMONG NINE OF THE 21 SAMPLES TESTED. THE SYRINGE USED IN THE MANUFACTURING OF THESE FINISHED GOODS IS A SUPPLIED ITEM. IT IS PURCHASED AS AN ASSEMBLED PRODUCT (SYRINGE BARREL, PLUNGER AND PLUNGER TIP RUBBER). BASED ON THE RESULTS OF THE PROVIDED RETURNED SAMPLES THE COMPLAINT WAS CONFIRMED, AND INADEQUATE MANUFACTURING FROM THE SUPPLIER IS THE ROOT CAUSE OF THIS ISSUE. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED FOR ANY NEW INFORMATION OR ADVERSE TRENDS AND FURTHER ACTIONS TAKEN ACCORDINGLY. DHR REVIEW FOUND NO DISCREPANCIES OR ANOMALIES RELEVANT TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED OUT AND DID NOT GET TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110595 JELCO EDGE 3ML NEEDLE W/ SYRINGE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 4141023 00351688071029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown