BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC 3 FEMALE INTERMITTENT CATHETER

    MDR report key: 4801946 · Received May 27, 2015

    Report

    Report Number
    1018233-2015-15072
    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 PATIENTS REQUIRING CATHETERIZATION, INCLUDING SELF-CATHETERIZATION, FOR MANAGEMENT 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 MAGIC3TM 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 LOCALIZED AND/OR SYSTEMIC INFECTIOUS COMPLICATIONS RANGING FROM URINARY TRACT INFECTION TO UROSEPSIS. IN THE EVENT THIS OCCURRED, THE PATIENT MAY REQUIRE MEDICAL INTERVENTION. THIS REPORT APPLIES TO: PRODUCT CODE 51614 - MAGIC 3 HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETERS 14 FR. LOT NUMBER 73600145. 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
    344573 MAGIC 3 FEMALE INTERMITTENT CATHETER FEMAILE INTERMITTENT CATHETER KOD ROCHESTER MEDICAL CORP NA 73600145

    Patients

    Seq Age Sex Outcome Treatment
    1