BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDIBLE BRUSH BACKFLUSH INSTRUMENT WITH ACTIVE

    MDR report key: 8363503 · Received February 22, 2019

    Report

    Report Number
    1222074-2019-00011
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    QDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION HAS SHOWN THAT THE PRODUCTS IN LOT 2000399465 HAVE A SWEEPER TIP INSTEAD OF A BACKFLUSH TIP. ALL OTHER PARTS OF THE INSTRUMENTS IN LOT 2000399465 ARE CORRECT. THE FAULTY TIP WAS CAUSED BY A PRODUCTION ERROR. A FIELD SAFETY CORRECTIVE ACTION WAS INITIATED TO WITHDRAW ALL PRODUCTS OF THE AFFECTED LOT FROM THE MARKET AND REPLACE THEM WITH THE CORRECT ASSEMBLED PRODUCTS. THE TOTAL LOT CONTAINED (B)(4) PRODUCTS ((B)(4)). PRODUCTS OF THE LOT WERE DISTRIBUTED TO DORC DISTRIBUTORS IN (B)(4). THE REMAINING 2 SETS WERE IN STOCK AND BLOCKED FOR DISTRIBUTION. A FIELD SAFETY NOTICE WAS SENT TO THE CUSTOMERS IN (B)(6), THE PRODUCTS DISTRIBUTED IN THE (B)(4) WERE WITHDRAWN FOLLOWING THE COMPLAINT (B)(4). ALL DISTRIBUTED PRODUCTS WERE RETURNED TO DORC. A DESIGN HISTORY REVIEW WAS PERFORMED. NO DEVIATIONS WERE FOUND IN THE PROCESS AND THE USED ARTICLES. TO PREVENT RECURRENCE, AN AWARENESS TRAINING FOR PRODUCTION STAFF INVOLVED IN THE AFFECTED LOT WAS PERFORMED.

    Description of Event or Problem · 1

    UPON OPENING THE PACKET AND EXTENDING THE TIP, THE PRODUCT WAS FOUND TO HAVE THE INCORRECT TIP ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157755 EXTENDIBLE BRUSH BACKFLUSH INSTRUMENT WITH ACTIVE VITRECTOMY FLUID/ GAS HANDLING HANDPIECE/CANNULA QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2000399465

    Patients

    Seq Age Sex Outcome Treatment
    1