BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML SYRINGE 22G X 1 RP

    MDR report key: 9098621 · Received September 20, 2019

    Report

    Report Number
    1017768-2019-00686
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    September 17, 2019
    Report Date
    January 27, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    UDI-DI
    20884521012711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO MANUFACTURING OR INSPECTION ANOMALIES INDICATIVE OF SYRINGE ISSUE. THERE WERE NO SAMPLES RETURNED WITH THIS COMPLAINT, HOWEVER A PHOTOGRAPH WAS SUBMITTED SHOWING A SYRINGE IN AN OPENED STATE WITH WHAT SEEMS TO BE PARTIAL PRINTED GRADUATION LINES NEAR THE THREE ML END; THE REPORTED CONDITION IS CONFIRMED. AS THE SYRINGE COULD NOT BE PHYSICALLY INSPECTED THE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE OF THIS TYPE OF CONDITION IS A TAPE FOLD OVER WHICH IS THE ONLY CONDITION THAT CAN BE SELF- CORRECTED. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE VISUALLY INSPECTED FOR DAMAGED AND MISSING COMPONENTS. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. AFTER REVIEWING THE COMPLAINT, IT DID NOT IDENTIFY ANY INDICATION OF A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS, SO A FORMAL CORRECTIVE/PREVENTATIVE ACTION (CAPA) WILL NOT BE ISSUED AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    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 CLINIC SAID SOME OF THE MARKINGS ARE MISSING OR VERY LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894140 3ML SYRINGE 22G X 1 RP SYRINGE, PISTON FMF COVIDIEN 8881513231 909142 20884521012711

    Patients

    Seq Age Sex Outcome Treatment
    1