BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS NEEDLES

    MDR report key: 22061673 · Received May 21, 2025

    Report

    Report Number
    3012307300-2025-05934
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 23, 2025
    Report Date
    August 18, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586033049
    PMA / PMN Number
    K072657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG: UPDATED. 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: DEVICE RECEIVED ON 6/25/2025. H3: THE RETURNED SAMPLE CONSISTED OF NINETEEN (19) KITS WITH THEIR ORIGINAL UNOPENED POUCHES INSIDE FROM A PLASTIC BAG. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 6061439 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER'S STATED PROBLEM WAS NOT CONFIRMED. ALL SAMPLES FUNCTIONED AS DESIGNED AND COMPLIED WITH EXPECTED SAFETY MECHANISM PERFORMANCE. NO FAILURES WERE DETECTED. THERE WAS NO KNOWN CAUSE OF THE REPORTED ISSUE, AND NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE END OF TREATMENT, WHEN THE NEEDLE WAS REMOVED USING THE SAFETY SYSTEM, THE NEEDLE CAME OUT OF THE SAFETY SYSTEM AND STABBED THE CAREGIVER. THERE WAS A RISK OF INJURY TO CAREGIVERS FROM A CONTAMINATED NEEDLE AND EXPOSURE TO BODILY FLUIDS. THE OUTCOME OF THE NEEDLE STICK INJURY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762405 DELTEC GRIPPER PLUS NEEDLES SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061439 10610586033049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown