BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC LUER ACTIVE Y-SITE GRIPPER PLUS HUBER NEEDLE

    MDR report key: 19302327 · Received May 13, 2024

    Report

    Report Number
    9617604-2024-00425
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 1, 2024
    Report Date
    August 1, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027734
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    D9. DATE RETURNED TO MFG: 31-MAY-2024. INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS RETURNED UNDER PART NUMBER 21-2965-24, L/N: 4420104 FOR EVALUATION WITHOUT ITS ORIGINAL PACKAGING, INSIDE A PLASTIC BAG IN DECONTAMINATED CONDITION. THE COMPLAINT SAMPLE WAS VISUALLY INSPECTED, AT 12¿ TO 16¿ UNDER NORMAL CONDITIONS OF ILLUMINATION. NO DAMAGE OR OTHER DEFECTS WAS DETECTED ON THE SAMPLE. THE SAMPLE WAS EVALUATED BY INTRODUCING DISTILLED WATER WITH A SYRINGE TO VERIFY THAT THE LIQUID FLOWED CORRECTLY. DURING THE FUNCTIONAL TEST IT WAS DETECTED THAT THE DISTILLED WATER PASSED THROUGH THE SAMPLE WITHOUT DIFFICULTY, NO OCCLUSION WAS DETECTED IN THE SAMPLE. THE FAILURE MODE ¿A0350 - OCCLUDED/BLOCKAGE¿ REPORTED IN THE COMPLAINT WAS NOT CONFIRMED. NO ROOT COULD BE DETERMINED BECAUSE THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUBER NEEDLE WAS UNABLE TO BE PRIMED BY FLUSHING WITH SALINE BEFORE ACCESSING THE PATIENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840476 DELTEC LUER ACTIVE Y-SITE GRIPPER PLUS HUBER NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4420104 10610586027734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown