BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLUGEL

    MDR report key: 2171410 · Received June 30, 2011

    Report

    Report Number
    3002037047-2011-00033
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ALCON - BELGIUM / S.A. ALCON - COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P990023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BATCH RECORDS WERE REVIEWED AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED SO FAR FOR THIS LOT. INVESTIGATION SHOWED THAT NO REMARKS RELATED TO THIS COMPLAINT IN BATCH RECORD VISUAL INSPECTION: ALL SYRINGES WERE VISUALLY INSPECTED, NO COMPONENT DEVIATIONS WERE REPORTED DURING THIS INSPECTION. A FUNCTIONALITY TEST WAS PERFORMED ON RETENTION SAMPLES, THE RESULT WAS ACCEPTABLE. INVESTIGATION OF THE COMPLAINT SAMPLE: ONE USED SYRINGE WITH ASSEMBLED LUER LOCK ADAPTER AND WITHOUT CANNULA WAS RECEIVED. A FUNCTIONALITY TEST WITH A REFERENCE CANNULA WAS PERFORMED, THE RESULT WAS ACCEPTABLE, THE CANNULA DIDN'T' DETACH. APPARENTLY THE CANNULA WAS NOT COMPLETELY ASSEMBLED ON THE SYRINGE BEFORE USE, WHICH CAUSED DETACHMENT OF THE CANNULA FROM THE SYRINGE. ROOT CAUSE HAS BEEN IDENTIFIED AS INCOMPLETE FIXATION OF THE CANNULA ON THE SYRINGE BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED, THE CANNULA DETACHED FROM THE SYRINGE WHEN THIS PRODUCT WAS INJECTED. HE STATED NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLUGEL AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM / S.A. ALCON - COUVREUR N.V. NA 10L10E

    Patients

    Seq Age Sex Outcome Treatment
    1