BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX HYPODERMIC NEEDLE-PRO EDGE SAFETY WITH SYRI

    MDR report key: 15398079 · Received September 11, 2022

    Report

    Report Number
    3012307300-2022-18615
    Event Type
    Malfunction
    Date Received
    September 11, 2022
    Date of Event
    October 29, 2020
    Report Date
    September 11, 2022
    Manufacturer
    NULL
    Product Code
    MEG
    PMA / PMN Number
    K061194
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL EXAMINATION OF THE PACKAGES REVEALED MISSING THE FILTER-PRO, AND MISSING THE SYRINGE AND FILTER-PRO, AND ONE WAS MISSING THE SYRINGE, THUS CONFIRMING THE COMPLAINT. NO EMPTY PACKAGES WERE OBSERVED. SINCE THE PACKAGES WERE SEALED, THE PROBLEM SOURCE FOR MISSING COMPONENTS IS ASSOCIATED WITH THE MANUFACTURING PROCESS AND MACHINE OPERATION. THE COMPLAINT HISTORY REVIEW SINCE OCTOBER 2019 FOUND NO TRENDS RELEVANT TO THIS PRODUCT OR CATEGORY. A QUALITY ALERT WAS ISSUED TO THE PRODUCTION FLOOR TO HEIGHTEN AWARENESS TO THIS POTENTIAL ISSUE. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED FOR ANY NEW INFORMATION OR ADVERSE TRENDS AND FURTHER ACTIONS WILL BE TAKEN ACCORDINGLY. MANUFACTURING SITE ADDRESS IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10009406, AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME PARTS WERE MISSING IN THE PACKAGE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139036 PORTEX HYPODERMIC NEEDLE-PRO EDGE SAFETY WITH SYRI SYRINGE, ANTISTICK MEG 3886660

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown