BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMITTENT HYDROPHILIC URINARY COUDE CATHETER

    MDR report key: 4534477 · Received February 17, 2015

    Report

    Report Number
    1018233-2015-00047
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 12, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP. 2130787
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS NOT ASSOCIATED WITH A CUSTOMER COMPLAINT OR REPORTED ADVERSE EVENT; HOWEVER, IT IS BEING FILED IN ACCORDANCE WITH 21CFR PART 803.53. INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    BARD MEDICAL DIVISION (BMD) WAS NOTIFIED BY THE BMD'S ROCHESTER MFG SITE THAT DURING LUBRICITY TESTING ON THE MAGIC 3 INTERMITTENT COUDE CATHETER, THREE UNITS OF PACKAGING WERE FOUND TO HAVE A BREACH IN THE STERILE BARRIER. THE REPORTED PRODUCT IS SOLD STERILE. ON (B)(6) 2015, IT WAS CONFIRMED THAT THIS LOT RELEASED INTO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113724 INTERMITTENT HYDROPHILIC URINARY COUDE CATHETER KOD ROCHESTER MEDICAL CORP. 2130787 NA 53621456

    Patients

    Seq Age Sex Outcome Treatment
    1