BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS NEEDLES

    MDR report key: 19467857 · Received June 5, 2024

    Report

    Report Number
    9617604-2024-00501
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 10, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586025594
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS RETURNED UNDER PART NUMBER 21-2766-24, L/N: 4426786 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 DID NOT PASS THROUGH THE SAMPLE. THE SAMPLE RETURNED WAS OCCLUDED. THE FAILURE MODE ¿A0350 - OCCLUDED/BLOCKAGE¿ REPORTED IN THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS NOT ESTABLISHED. 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.

    Additional Manufacturer Narrative · 0

    B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. 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 "DRUG DID NOT ROUTE DURING FRESH FOOD FLUSH PRIOR TO PATIENT USE". THIS OCCURRED DURING PRIMING, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823507 DELTEC GRIPPER PLUS NEEDLES SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4426786 10610586025594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown