BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYE PACK

    MDR report key: 10534805 · Received September 14, 2020

    Report

    Report Number
    MW5096598
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 10, 2020
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON APPLIED A 30 GAUGE CANNULA TO A 3 ML BSS SYRINGE FROM THE EYE PACK. WHEN SURGEON ATTEMPTED TO USE ON THE PATIENT'S EYE, THE 30 GAUGE CANNULA TIP BECAME DISLODGED FROM THE SYRINGE PRIOR TO INSERTING IT INTO THE EYE. SYRINGE AND CANNULA DISCARDED AND REPLACED WITH NEW SYRINGE AND CANNULA. NO HARM TO PATIENT. ADDENDUM 9/1/2020: CASE SUBMITTED TO PA PSRS AS INCIDENT ON (B)(6) 2020. AFTER FURTHER REVIEW/INFORMATION, DURING PROCEDURE DISLODGEMENT OF CANNULA FROM SYRINGE THAT ENTERED THE RIGHT EYE CAUSED AN INJURY, WHICH WAS FOUND TO BE VIOLATION OF POSTERIOR CAPSULE AND RETINAL TEAR. PATIENT NEEDED RETURN TO SURGERY FOR PARS PLANA VITRECTOMY, PERFLUORON C3F8 16% AND LASER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997459 EYE PACK EYE TRAY OJK MEDLINE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R