BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACKFLUSH HANDLE DSP, 23 GA, SOFT TIP

    MDR report key: 1759744 · Received June 24, 2010

    Report

    Report Number
    3003398873-2010-00006
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 10, 2010
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT IMPACT REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "TIGHT FITTING CANNULA" (FITTING PROBLEM). A CUSTOMER REPORTED THAT THE CANNULA HAD AN AREA WHERE THE DIAMETER WAS SLIGHTLY BIGGER AND DID NOT FIT WITH THE TROCAR 23 GA. WHEN THE CUSTOMER TOOK THE BACKFLUSH "CANNULA" TO INSERT IT INTO THE TROCAR HE FELT SOME RESISTANCE. AFTER SEVERAL ATTEMPTS, HE REALISED THAT THE CANNULA ENTERED JUST FOR 1 CM IN THE TROCAR. THE CUSTOMER OBSERVED THE PRODUCT UNDER THE MICROSCOPE AND DETECTED THAT AT ABOUT 1.5 CM FROM THE NEEDLE TIP, THE DIAMETER INCREASED SO THAT IT WAS NOT POSSIBLE TO INSERT THE BACKFLUSH INTO THE TROCAR. NO PT IMPACT WAS REPORTED. ADDITIONAL F/U INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACKFLUSH HANDLE DSP, 23 GA, SOFT TIP BACKFLUSH HANDLE, ACCESSORY OPHTHALMIC HQC ALCON GRIESHABER AG 337.76 F76065

    Patients

    Seq Age Sex Outcome Treatment
    1