BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2042554 · Received April 6, 2011

    Report

    Report Number
    2210968-2011-00387
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    NI
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/06/2011. (B)(4) - TROCAR SLEEVE DIFFICULT TO REMOVE. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCRUB NURSE WAS REMOVING THE PLASTIC PROTECTION OFF THE TROCAR AND STABBED HERSELF WITH THE POINT ON (B)(6) 2011. THE TROCAR HAD NOT BEEN USED ON A PATIENT. ANOTHER DRAIN HAD TO BE USED DUE TO CONTAMINATION. THE WOUND DID NOT REQUIRE SUTURING AND THE NURSE WAS FINE AND CONTINUED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG NI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1