BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER MICRO NEEDLES

    MDR report key: 19425055 · Received May 30, 2024

    Report

    Report Number
    9617604-2024-00488
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 27, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30610586029886
    PMA / PMN Number
    K072059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DAY OF EVENT IS UNKNOWN. E1: (B)(6). 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

    THE FOLLOWING FIELD WAS UPDATED WITH CORRECTIONS: D4. PRIMARY UDI NUMBER: (B)(4). H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS RETURNED UNDER PART NUMBER 21-3271-24, L/N: 4426823 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 WERE 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 OCCLUSIONS WERE DETECTED IN THE SAMPLE. THE REPORTED FAILURE MODE IN THE COMPLAINT WAS NOT CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. 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 THERE WAS A TUBE OCCLUSION. WHEN TRYING TO PASS SALINE THROUGH THE TUBE BEFORE USE ON THE PATIENT, IT DID NOT PASS. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099036 DELTEC GRIPPER MICRO NEEDLES SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4426823 30610586029886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown