BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 12331086 · Received August 17, 2021

    Report

    Report Number
    1423395-2021-00037
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 17, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    LRO
    UDI-DI
    10080196927159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT, DURING CATARACT SURGERY, THE EYE SPEAR COMPONENT WAS NOTED TO BE "DISINTEGRATING" AND THAT EYE SPEAR MATERIAL WAS NOTED ON THE PATIENT'S EYE. WHEN THE REPORTED PRODUCT PROBLEM/ISSUE WAS IDENTIFIED, THE EYE SPEAR MATERIAL WAS REMOVED FROM THE PATIENT'S EYE VIA AN UNSPECIFIED METHOD AND NO FURTHER INCIDENT WAS REPORTED. NO ADVERSE PATIENT IMPACT AND NO FURTHER MEDICAL INTERVENTION OR FOLLOW-UP CARE WAS REPORTED. A SAMPLE OF SIX (6) UNUSED EYE SPEARS WERE RETURNED FOR EVALUATION. THE WHITE TIPS OF THE EYE SPEAR COMPONENTS WERE OBSERVED TO BE FRAYED WITH ROUGH CUT EDGES AND SMALL PIECES OF THE WHITE MATERIAL STICKING OUT AND LOOSELY ATTACHED. IT WAS NOTED THAT, WITH VERY LITTLE FORCE APPLIED, THE SMALL LOOSE PIECES COULD BE EASILY DETACHED FROM THE REST OF THE EYE SPEAR COMPONENT. TRENDING WAS PERFORMED AND NO ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT PROBLEM/ISSUE WERE IDENTIFIED IN THE LAST SIX (6) MONTHS. THE EYE SPEAR COMPONENT IS RECEIVED FROM (B)(4) MEDICAL INC. IN SUPPLIER PACKAGING AND IS NOT ALTERED DURING PACK ASSEMBLY. THE ROOT CAUSE WAS DETERMINED TO BE AN ERROR IN THE SUMMIT MEDICAL INC. MANUFACTURING PROCESS AND THE SUPPLIER WAS NOTIFIED OF THE PRODUCT PROBLEM/ISSUE. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION TO REMOVE THE EYE SPEAR MATERIAL FROM THE PATIENT'S EYE, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EYE SPEAR COMPONENT WAS LINTING MATERIAL DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231319 MEDLINE INDUSTRIES, INC. EYE SPEAR IN EYE II LRO MEDLINE INDUSTRIES INC. DYNJS0120 21DDA980 10080196927159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention