BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC 3 FEMALE INTERMITTENT CATHETER

    MDR report key: 4801885 · Received May 27, 2015

    Report

    Report Number
    1018233-2015-15051
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS NOT ASSOCIATED WITH A REPORTED ADVERSE EVENT, HOWEVER, IT IS BEING FILED IN ACCORDANCE WITH 21 CFR PART 803.53. THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PTS REQUIRING CATHETERIZATION, INCLUDING SELF-CATHETERIZATION, FOR MGMT OF INCONTINENCE, VOIDING DYSFUNCTION, OR SURGICAL PROCEDURES AS A RESULT OF PREEXISTING OR ACUTE CONDITIONS SUCH AS SPINA BIFIDA, SPINAL TRAUMA, OR OTHERS. USE OF NON-STERILE MAGIC3 HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETERS COULD INTRODUCE MICROORGANISMS TO THE URINARY TRACT DURING A CATHETERIZATION PROCEDURE WHICH MAY LEAD TO A VARYING DEGREE OF RISK INCLUDING LOCALIZE AND/OR SYSTEMIC INFECTIOUS COMPLICATIONS RANGING FROM URINARY TRACT INFECTION TO UROSEPSIS. IN THE EVENT THIS OCCURRED, THE PT MAY REQUIRE MED INTERVENTION. THIS REPORT APPLIES TO: 51614 - MAGIC 3 HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETERS 14 FR LOT NUMBER 73600007. ALL INVESTIGATIONS WILL BE LINKED TO INVESTIGATION NUMBER (B)(4).

    Description of Event or Problem · 1

    BARD MEDICAL (BMD) HAS CONFIRMED THAT AN EVENT OCCURRED INVOLVING 45 LOTS OF 5 PRODUCT CODES. AS A RESULT, THESE PRODUCTS ARE AT RISK FOR HAVING A SMALL VOID IN THE PACKAGE SEAL AND PRODUCT STERILITY MAY BE AFFECTED. FORTY-TWO OF THESE LOTS WERE SHIPPED TO CUSTOMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343880 MAGIC 3 FEMALE INTERMITTENT CATHETER KOD ROCHESTER MEDICAL CORP 73600007

    Patients

    Seq Age Sex Outcome Treatment
    1