BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATION NEEDLE

    MDR report key: 1911962 · Received December 1, 2010

    Report

    Report Number
    3005075853-2010-06776
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FDP
    PMA / PMN Number
    K910875
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED UPON THE VISUAL AND FUNCTIONAL EXAMINATION, IT WAS CONCLUDED THAT THE NEEDLE STYLET WAS BLOCKED WITH EXCESS ADHESIVE. THE DEVICE WAS RECEIVED WITH DRIED BODY FLUIDS ON IT. ANALYSIS CONFIRMS THE CUSTOMERS COMPLAINT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE, THEY COULD NOT PUT WATER INTO THE NEEDLE. IT WAS BLOCKED. A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATION NEEDLE NSUFFLATION NEEDLE - 120MM LENGTH FDP ETHICON ENDO-SURGERY, LLC. NA G4TL6Y

    Patients

    Seq Age Sex Outcome Treatment
    1