BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD COUDE TIP LATEX URETHRAL FOLEY CATHETER (TIEMANN MODEL) ONE EYE

    MDR report key: 6392259 · Received March 9, 2017

    Report

    Report Number
    1018233-2017-00996
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Report Date
    June 22, 2017
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    EZC
    PMA / PMN Number
    K910197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    NO PHYSICAL SAMPLE WAS RECEIVED; HOWEVER, A PHOTO WAS RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THE PICTURE, IT WAS NOTED THAT THE LABEL OF THE CASE AND THE LABEL OF THE INDIVIDUAL PACKAGE SHOW DIFFERENT A PRODUCT AND LOT. THE INDIVIDUAL PACKAGE WAS FOR CATALOG 802520 AND LOT NGAU4647. HOWEVER, THE CASE LABEL WAS FOR CATALOG 010112 AND LOT NGAR0730. BASED ON THE PHOTO, IT IS OBSERVED THAT THE BOX DOES NOT HAVE THE ORIGINAL SEAL FROM THE PLANT. PER THE SUMMARY ATTACHED TO THE INVESTIGATION, BASED ON THE DHR REVIEW OF THE SUBJECT LOTS (NGAR0730 AND NGAU4647), THE MIX COULD NOT HAVE OCCURRED IN MANUFACTURING, AS THE LOTS WERE MANUFACTURED ON DIFFERENT DATES, MACHINES AND LINES. THEY WERE ALSO SHIPPED WITH A DIFFERENCE OF 106 DAYS OF EACH OTHER. THEREFORE THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "FOR UROLOGICAL USE ONLY. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. WARNINGS: ON LATEX AND RED RUBBER CATHETERS, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO FAILURE, AND/OR TO INJURY, ILLNESS OR DEATH OF THE PATIENT. INSTRUCTIONS FOR INTERMITTENT CATHETERS: WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. REMOVE CATHETER FROM THE PACK. POSITION YOURSELF COMFORTABLY, CLEANING THE OPENING OF THE URETHRA AND SURROUNDING AREA. GENTLY INSERT ROUNDED END OF CATHETER INTO URETHRA. WHEN URINE STOPS FLOWING, REMOVE CATHETER FROM URETHRA. DISPOSE OF CATHETER IN ACCORDANCE WITH LOCAL RULES AND REGULATIONS. WASH YOUR HANDS." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THERE WAS THE WRONG PRODUCT INSIDE. THE PRODUCT INSIDE OF THE BOX WAS 802520 LOT NGAU4647.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THERE WAS THE WRONG PRODUCT INSIDE. THE PRODUCT INSIDE OF THE BOX WAS 802520 LOT NGAU4647.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174356 BARD COUDE TIP LATEX URETHRAL FOLEY CATHETER (TIEMANN MODEL) ONE EYE COUDE CATHETER EZC PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAR0730

    Patients

    Seq Age Sex Outcome Treatment
    1