BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10906998 · Received November 25, 2020

    Report

    Report Number
    1423395-2020-00036
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    August 4, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OJK
    UDI-DI
    10193489237580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA MEDWATCH REPORT (MW5096598) THAT DURING A PROCEDURE DISLODGEMENT OF A CANNULA FROM A SYRINGE THAT IT ENTERED THE RIGHT EYE OF A PATIENT AND CAUSED AN INJURY. EMAIL RECEIVED BY CLINICAL RISK COORDINATOR, (B)(6) MEDICAL CENTER, WHO PROVIDED ADDITIONAL INFORMATION IN REGARDS TO THIS REPORTED INCIDENT. REPORTER STATES THAT ON (B)(6) 2020 A (B)(6) MALE ARRIVED AT THE MEDICAL CENTER FOR A RIGHT CATARACT REMOVAL. REPORTER STATES, "A SURGEON APPLIED 30-GAUGE CANNULA TO A 3ML BSS SYRINGE FROM THE EYE PACK. WHEN SURGEON ATTEMPTED TO USE ON THE PATIENT'S EYE, THE 30-GAUGE CANNULA TIP BECAME DISLODGED AND SHOT THROUGH THE CAPSULE INTO THE ANTERIOR VITREOUS OF THE PATIENT'S EYE." THE REPORTER STATES, THE CANNULA WAS REMOVED. REPORTER STATES, "VIOLATION NOTED IN POSTERIOR CAPSULE, INTRAOCULAR LENS IMPLANT WELL CENTERED AND STABLE, CONFIRMED WITH OSHER BOUNCE TEST." REPORTER STATES, UPON POST-OP FOLLOW-UP "NOTED RETINAL TEAR TO RIGHT EYE, BARRIER LASER TO RIGHT EYE, CONTINUED WITH CLINIC FOLLOW-UP. NOTED TO HAVE GIANT RETINAL TEAR EXTENDING THROUGH LASER WITH RETINAL DETACHMENT REQUIRING SURGICAL INTERVENTION." REPORTER STATES, PATIENT "RETURNED TO OPERATING ROOM ON (B)(6) 2020 FOR PARS PLANA VITRECTOMY, PERFLUORON C3F8 16% AND LASER." NO REPORTS PROVIDED AS TO HOW THE PATIENT IS DOING AT THIS TIME. NO SAMPLE PROVIDED FOR RETURN AND EVALUATION. ROOT CAUSE ANALYSIS; WITHOUT A SAMPLE, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE. ACTIONS TAKEN AND RECOMMENDATIONS: OUR SUPPLIER QUALITY TEAM WILL MONITOR THIS ISSUE FOR TRENDING PURPOSES." DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH REPORT (MW5096598) THAT DURING A PROCEDURE DISLODGEMENT OF A CANNULA FROM A SYRINGE THAT IT ENTERED THE RIGHT EYE OF A PATIENT AND CAUSED AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364329 MEDLINE INDUSTRIES, INC. DBD-EYE PACK OJK MEDLINE INDUSTRIES INC. DYNJ59172B 10193489237580

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR