BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLUGEL

    MDR report key: 2181427 · Received July 6, 2011

    Report

    Report Number
    3002037047-2011-00040
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 6, 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: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. AFTER PREVIOUS SIMILAR COMPLAINTS, INVESTIGATION OF THE PREVIOUS COMPLAINT SAMPLES HAVE BEEN PERFORMED BY THE MANUFACTURER OF THE SYRINGES. RESULTS OF THESE INVESTIGATIONS SHOWED THAT THERE WERE NO DEVIATIONS RELATED TO THE INDIVIDUAL COMPONENTS. DIMENSIONS AND FUNCTIONALITY WERE TESTED AND CONFORMED FOR THE (B)(4) BARREL AS WELL AS THE (B)(4) LUER-LOK (LLA). AFTER REASSEMBLY OF THE LLA, IT WAS NOT POSSIBLE TO SIMULATE DETACHMENT ON THE COMPLAINT SAMPLES ACCORDING TO THE DIRECTIONS FOR USE (DFU). HOWEVER, WHEN THESE INSTRUCTIONS FOR USE WERE NOT FOLLOWED OR IF OTHER NON-ALCON COMPONENTS WERE USED A MALFUNCTIONING OF THE DEVICE COULD BE SIMULATED. THE FACT THAT THE COMPLAINTS THAT WERE RECEIVED UP TO NOW ARE OFTEN CLUSTERED, MIGHT INDICATE THAT THE DIRECTIONS FOR USE ARE NOT ALWAYS FOLLOWED CORRECTLY BY SOME CUSTOMERS. AT THIS TIME ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, REITERATION OF THE CORRECT INSTRUCTIONS FOR USE IS THE RECOMMENDED ACTION. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED THE LUER-LOK AND CANNULA DETACHED FROM THE SYRINGE DURING USE OF THIS PRODUCT. THE FACILITY REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION. PATIENT IMPACT REMAINS UNKNOWN.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1