BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® ALL PURPOSE URETHRAL CATHETER

    MDR report key: 8200616 · Received December 27, 2018

    Report

    Report Number
    1018233-2018-06217
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Report Date
    March 1, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741034039
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿DAVOL®ALL-PURPOSE URETHRAL CATHETER CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. WITH FUNNEL END 16¿ (40.6CM) LENGTH, TWO EYES, X-RAY OPAQUE RUBBER. WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. 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 DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. FOR UROLOGICAL USE ONLY. U.S. PRODUCT. PACKAGED IN MEXICO CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SINGLE USE CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX. LOT NUMBER CATALOG NUMBER DO NOT RESTERILIZE. CAUTION, CONSULT ACCOMPANYING DOCUMENTS. DO NOT USE IF PACKAGE IS DAMAGED UNITS KEEP AWAY FROM SUNLIGHT WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. CONSULT INSTRUCTIONS FOR USE. STERILIZED USING ETHYLENE OXIDE BARD AND DAVOL ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EYELET ON THE CATHETER WAS SHARP. ALLEGEDLY, THE EYELET CUT SOME TISSUE DURING REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EYELET ON THE CATHETER WAS SHARP. ALLEGEDLY, THE EYELET HAVE "CUT SOME TISSUE" DURING REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037576 BARD® ALL PURPOSE URETHRAL CATHETER URETHRAL CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 0094160 UNK 00801741034039

    Patients

    Seq Age Sex Outcome Treatment
    1