BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MAGIC3 COUDE HYDROPHLIC 14FR MALE 30BX

    MDR report key: 6002597 · Received October 6, 2016

    Report

    Report Number
    1018233-2016-01352
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ROCHESTER MEDICAL CORP 2130787
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "INTENDED USE: THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. PLEASE CONTACT YOUR PHYSICIAN TO DETERMINE WHICH PRODUCT OPTIONS ARE BEST FOR YOU, PAYING CLOSE ATTENTION TO PRODUCT WARNINGS/ PRECAUTIONS AND ADVERSE REACTIONS. THE CATHETER BECOMES SLIPPERY WHEN WETTED WITH WATER, ELIMINATING THE NEED FOR A SEPARATE LUBRICANT. FOR YOUR ADDED CONVENIENCE, THIS CATHETER IS PACKAGED WITH ITS OWN STERILE WATER. SIMPLY RELEASE THE WATER FROM ITS FOIL PACKET AND THEN TIP THE UN-OPENED CATHETER PACKAGE END-TO-END. THE CATHETER ACTS LIKE A MAGNET TO ATTRACT THE WATER AND ACTIVATE ITS SLIPPERY COATING. FOLLOW THESE STEPS FOR BEST RESULTS. RELEASE THE WATER. PRIOR TO OPENING THE SEALED CATHETER POUCH: APPLY PRESSURE TO THE FOIL PACKET TO RELEASE THE WATER. ENSURE ALL WATER IS RELEASED FROM THE FOIL PACKET. WET THE CATHETER. HOLD PACKAGE WITH PRINTED SIDE UP. TIP PACKAGE END-TO-END THREE TO SIX TIMES TO WET CATHETER. THIS MOVEMENT IS REQUIRED SO THAT THE WATER TRANSFERS BACK AND FORTH OVER THE CATHETER TO FULLY WET THE HYDROPHILIC COATING. USE THE CATHETER. PEEL BACK PACKAGE TO EXPOSE FUNNEL END OF CATHETER. IF DESIRED, USE THE SELF-ADHESIVE TAPE ON THE PACKAGE. TO TEMPORARILY ATTACH THE POUCH TO ANY DRY VERTICAL SURFACE. REMOVE CATHETER AND USE ACCORDING TO PHYSICIAN'S INSTRUCTIONS. WARNING: THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE, DO NOT RESTERILIZE. MADE OF SILICONE ELASTOMER. PRESCRIPTION ONLY. SINGLE USE. NOT MADE WITH NATURAL RUBBER LATEX. NOT MADE WITH PVC. DO NOT USE IF PACKAGE IS DAMAGED. STERILIZED USING IRRADIATION." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO EYE IN THE CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO EYE IN THE CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO EYE IN THE CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661428 ROCHESTER MAGIC3 COUDE HYDROPHLIC 14FR MALE 30BX MAGIC 3 CATHETER KOD ROCHESTER MEDICAL CORP 2130787 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1