BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1® FOLEY CATHETER TEMPERATURE SENSOR

    MDR report key: 7584215 · Received June 8, 2018

    Report

    Report Number
    3012307300-2018-02349
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    May 14, 2018
    Report Date
    September 4, 2018
    Manufacturer
    SMITHS MEDICAL, ASD, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EXPIRATION AND MANUFACTURE DATES COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    TWO LEVEL 1® FOLEY CATHETER TEMPERATURE SENSOR DEVICES WERE EXAMINED, ONE UNUSED, THE OTHER USED. THE UNUSED DEVICE WAS FOUND TO CONFORM TO PRODUCTS SPECIFICATIONS AND NO DEFECTS WERE FOUND. THE USED DEVICE WAS FOUND TO HAVE A PIN HOLE IN THE CUFF. THE SUPPLIER STATED THAT "A PINHOLE CAN BE CAUSED BY EFM OR SILICONE MATERIALS EMBEDDED IN THE WALLS OF THE CUFF, CAUSING A SECTION OF THE WALL TO BE LESS RESISTANT AND WHEN INFLATED THEY ARE PROJECTED AND CREATE A HOLE." ALTHOUGH THIS IS NOT THE DEFINITIVE ROOT CAUSE, IT IS ONLY A POSSIBILITY. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS ALSO PERFORMED. L/N: 970303 MANUFACTURE START DATE 10/23/17. ALL MATERIAL VERIFICATIONS, LINE CLEARANCES, AND QC INSPECTIONS WERE PERFORMED BY TRAINED XERIDIEM PERSONNEL. 12/27/17, (B)(4) UNITS WERE RELEASED TO SPECIFICATION. THERE WERE (B)(4) UNITS SCRAPPED DUE TO PINHOLES AND ZERO NONCONFORMANCE'S INITIATED WITH THE LOT. THE COMPLAINT RECORDS WERE REVIEWED FOR THE PREVIOUS YEAR (JUNE 2017 - JUNE 2018). FOR THE 70-0025 PRODUCT FAMILY AND SPECIFIC PART NUMBER 70-0025-116 THERE HAS BEEN 1 COMPLAINT FILED FOR THE CONFIRMED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OBSTRUCTION HAS OCCURRED IN THE PATIENT'S CATHETER THIS WEEKEND WHILE USING A LEVEL 1® FOLEY CATHETER TEMPERATURE SENSOR. THIS CAUSED BLADDER RETENTION AND RENAL DYSFUNCTION. NO OTHER ADVERSE HEALTH OUTCOMES REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER RESPONSE WAS RECEIVED ON (B)(6) 2018 FOR THE FOLLOWING QUESTIONS: Q: WHAT MEDICAL INTERVENTION WAS PROVIDED TO ADDRESS THE RENAL DYSFUNCTION? A:THE URINARY CATHETER HAS BEEN REPLACED SO THAT THE URINE COULD RUN OFF AGAIN. Q: WHAT WAS THE OUTCOME OF THE RENAL DYSFUNCTION? A: UNFORTUNATELY, THE CLIENT CANNOT GIVE US ANY MORE INFORMATION. BASED ON THE ADDITIONAL INFORMATION ABOVE, THE COMPLAINT REMAINS UNCHANGED AS A SERIOUS INJURY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425126 LEVEL 1® FOLEY CATHETER TEMPERATURE SENSOR CATHETER, UROLOGICAL KOD SMITHS MEDICAL, ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention