BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    135 S-PLK X SP NO LOGO

    MDR report key: 11665642 · Received April 14, 2021

    Report

    Report Number
    1915484-2021-01228
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Report Date
    June 16, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    UDI-DI
    10884521010819
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PEASE SEE SECTION H4 FOR DEVICE MANUFACTURE DATE INFORMATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER 902834 WAS REVIEWED. THIS PRODUCT WAS MANUFACTURED AND PACKAGED ON JANUARY 19, 2019 AND PACKAGED ON JANUARY 20, 2019. THE DEVICE HISTORY RECORD FOR THE LOT CONTROL INDICATES THAT PRODUCT AND SPECIFICATION REQUIREMENTS WERE MET WITH NO NON-CONFORMING PRODUCT IDENTIFIED RELATING TO THE REPORTED ISSUE. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THE MANUFACTURING SITE DID NOT RECEIVE ANY PHYSICAL SAMPLES FOR THE EVALUATION; HOWEVER, TWO PICTURES HAS BEEN PROVIDED FOR THE ANALYSIS. UPON VISUAL EVALUATION, A BROKEN OR POTENTIAL SHORT SHOT TIP CAN BE OBSERVED. IT IS UNKNOWN WHETHER THE EDGES OF THE TIP PRESENT ARE SHARP OR SMOOTH. WITHOUT A PHYSICAL SAMPLE BEING RETURNED, A MORE THOROUGH INVESTIGATION CANNOT BE PERFORMED, AND THE REPORTED ISSUE CANNOT BE CONFIRMED TO BE MANUFACTURING-RELATED; HOWEVER, SOME POTENTIAL ROOT CAUSES FOR A SHORT SHOT IN THE TIP CAN BE DUE TO VARIABLE MOLD SETUP PARAMETERS SUCH AS THE SHOT SIZE WHICH DETERMINES THE PACK PRESSURE OF THE MELTED RESIN. SOME POTENTIAL ROOT CAUSES FOR BROKEN TIP COULD HAVE OCCURRED DURING TRANSPORT OF THE MOLDED COMPONENTS OR SUBASSEMBLIES, DURING POTENTIAL FURTHER PROCESSING BY THE CUSTOMER OR END USER, OR DUE TO HANDLING OR TECHNIQUE BY THE END USER. ALL LOTS AND SHOP ORDERS ARE VISUALLY AND PHYSICALLY INSPECTED TO THE QUALITY INSPECTION STANDARD AND THE STATISTICAL SAMPLING MUST MEET THE ACCEPTABLE QUALITY LIMIT REQUIREMENTS DURING THE MOLDING AND ASSEMBLY PROCESS. A LOT CANNOT BE RELEASED UNLESS IT PASSES SPECIFICATION REQUIREMENTS. THIS SYRINGE IS INTENDED TO BE A SINGLE USE SYRINGE AND NOT QUALIFIED AS A PREFILL SYRINGE. A QUALITY ALERT WILL BE DISTRIBUTED TO NECESSARY PRODUCTION AND QUALITY PERSONNEL TO HEIGHTEN AWARENESS OF THE REPORTED CONDITION. BASED ON ALL AVAILABLE INFORMATION THE DEFINITE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYRINGE WAS FOUND WITH SHORT SHOT IN THE TIP. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561777 135 S-PLK X SP NO LOGO SYRINGE, PISTON FMF COVIDIEN 8881135019 902834 10884521010819

    Patients

    Seq Age Sex Outcome Treatment
    1