BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER WITH TEMPERATURE SENSOR

    MDR report key: 4692158 · Received April 14, 2015

    Report

    Report Number
    2320762-2015-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    March 13, 2015
    Report Date
    April 10, 2015
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    EZL
    PMA / PMN Number
    K063442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONTAINS RAW MATERIAL (B)(4) LOT NUMBER B0752303-NL. THE REP SAMPLE WAS RETURNED TO THE QC COMPLAINT SPECIALIST AND CONSISTED OF (B)(4) EACH OF THE DEVICES STILL SEALED WITHIN DEROYAL PACKAGING. VIA PHONE CALL WITH (B)(4) IT HAS BEEN DETERMINED TO PROVIDE THE SAMPLE TO BRANCH PLANT (B)(4) FOR EVAL AND JOINT INVESTIGATION PROCESS. THE QFI REPORT WAS REVIEWED FOR SALES AND SIMILAR COMPLAINT INFO. DEROYAL HAS SOLD (B)(4) OF THE FINISHED GOOD FROM 2013 TO 2015. THERE HAVE BEEN NO PREVIOUS REPORTS RECEIVING DURING THE REVIEW PERIOD FOR THE FINISHED GOOD REFERRING TO A TEMP ISSUE. INVESTIGATION IS INCOMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED AS MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE TEMP PROBE FOR THIS LOT NUMBER IS NOT MEASURING ACCURATE TEMP SETTINGS. IT IS RUNNING ANYWHERE FROM 32-35 DEGREES. THEY ARE USING AN ESOPHAGEAL STETHOSCOPE AS A BASELINE AND IT IS REGISTERING RIGHT AT 36 DEGREES. THE ESOPHAGEAL AND THE FOLEY PROBE SHOULD BE THE SAME READINGS OF VERY CLOSE, CERTAINLY NOT 3 DEGREES DIFFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248478 FOLEY CATHETER WITH TEMPERATURE SENSOR EZL DEROYAL INDUSTRIES 36785559

    Patients

    Seq Age Sex Outcome Treatment
    1