BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMITTENT CATHETER

    MDR report key: 15269932 · Received August 22, 2022

    Report

    Report Number
    1018233-2022-06618
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    August 11, 2022
    Report Date
    September 7, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBM
    PMA / PMN Number
    K111405
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL FAILURE MODE COULD BE "CATHETER TIP TOO SHARP" AND A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE " UNPOLISHED MOLD SURFACE AND INCORRECT TIPPING PARAMETERS". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INSTRUCTIONS FOR INTERMITTENT CATHETERS: 1. WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. 2. REMOVE CATHETER FROM THE PACK. 3. POSITION YOURSELF COMFORTABLY, CLEANING THE OPENING OF THE URETHRA AND SURROUNDING AREA. IF DESIRED, APPLY WATER-SOLUBLE LUBRICANT TO CATHETER. 4. GENTLY INSERT ROUNDED END OF CATHETER INTO URETHRA UNTIL URINE BEGINS TO FLOW. 5. WHEN URINE STOPS FLOWING, REMOVE CATHETER FROM URETHRA. 6. DISPOSE OF CATHETER IN ACCORDANCE WITH LOCAL RULES AND REGULATIONS. 7. WASH YOUR HANDS." H11: SECTION A THROUGH F - 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN USING LIBERATOR MEDICAL SUPPLY FOR 4 YEARS OR A LITTLE OVER. PATIENT HAD 2 URINARY TRACT INFECTIONS WITHIN THE LAST 90 DAYS AND FOUND THAT THE INTERMITTENT CATHETERS WERE SO SHARP, AND THE PATIENT DROPPED A CATHETER ON THE FLOOR AND WENT TO PICK IT UP AND NOTICED IT WAS NOT SMOOTH AND IT WAS ROUGH. PATIENT WENT TO THE EMERGENCY ROOM YESTERDAY AND THEY PUT ANTIBIOTIC FOR THE PATIENT AND STATED IT WAS ROUGH ALL THE WAY AND THE PATIENT DID NOT WANT PRE-LUBRICATED CATHETERS BECAUSE THE PATIENT HAD A HARD TIME OPENING THING. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN USING LIBERATOR MEDICAL SUPPLY FOR 4 YEARS OR A LITTLE OVER. PATIENT HAD 2 URINARY TRACT INFECTIONS WITHIN THE LAST 90 DAYS AND FOUND THAT THE INTERMITTENT CATHETERS WERE SO SHARP, AND THE PATIENT DROPPED A CATHETER ON THE FLOOR AND WENT TO PICK IT UP AND NOTICED IT WAS NOT SMOOTH AND IT WAS ROUGH. PATIENT WENT TO THE EMERGENCY ROOM YESTERDAY AND THEY PUT ANTIBIOTIC FOR THE PATIENT AND STATED IT WAS ROUGH ALL THE WAY AND THE PATIENT DID NOT WANT PRE-LUBRICATED CATHETERS BECAUSE THE PATIENT HAD A HARD TIME OPENING THING. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389532 INTERMITTENT CATHETER INTERMITTENT CATHETER GBM C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other