BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL PURPOSE TEMPERATURE PROBE

    MDR report key: 11744372 · Received April 29, 2021

    Report

    Report Number
    9613793-2021-00011
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 29, 2021
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FLL
    UDI-DI
    00749756046145
    PMA / PMN Number
    K925791
    Removal / Correction Number
    MW5100669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDING: MANUFACTURING PLANT INSPECTED A TOTAL OF (B)(4) UNITS AND ALL PARTS WERE FOUND IN COMPLIANCE WITH THE PROCESS SPECIFICATIONS. PAST COMPLAINT LOGS HAVE BEEN REVIEWED AND CONFIRMED OF NO SIMILAR ISSUES HAVE BEEN REPORTED. ROOT CAUSE: NO ROOT CAUSE DETERMINED. THE SUS INVOLUNTARY REPORT (MW5100669) STATED THE FOLLOWING, "PATIENT WAS AGITATED IN ICU AND MAY HAVE BITTEN THROUGH THE WIRE." LOT INFORMATION PROVIDED BY THE CUSTOMER DOES NOT MATCH ANY OF THE COMPANY'S DEVICE HISTORY RECORDS (DOES NOT EXIST). THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER A PIECE OF THE TEMPERATURE PROBE WAS BROKEN OFF AND FOUND INSIDE THE PATIENT STOMACH. PATIENT POTENTIALLY BIT OFF THE PROBE PER SUS VOLUNTARY EVENT REPORT (MW5100669). THE SUS VOLUNTARY EVENT REPORT STATED THE FOLLOWING: PATIENT COMPLAINS OF ABDOMEN DISTENTION AND NAUSEA. ABDOMEN WITHOUT PERITONITIS OR GUARDING. OBSTRUCTION SERIES SHOWS DILATED SMALL BOWL, AIR IN COLON CONCERN FOR ILEUS. BUT ALSO SHOWS A RETAINED OBJECT IN LUQ THAT IS CONCERNING FOR PORTION OF DOBHOFF TUBE (FEEDING TUBE) VS ESOPHAGEAL TEMP PROBE THAT APPEARS TO BE IN THE STOMACH. CHEST X-RAY SHOWED INTACT DOBHOFF COURSING THROUGH ESOPHAGUS INTO STOMACH GI CONSULTED FOR ESOPHAGOGASTRODUODENOSCOPY (EGD). EGD APPEARED TO BE A FRACTURED DOBHOFF TUBE IN THE BODY OF THE STOMACH THAT EXTENDED INTO THE ANTRUM AND INTO THE DUODENUM. SOME GASTRITIS WITH HEMATIN LIKELY FROM THE TRAUMA FROM THE PRESENCE OF A FOREIGN BODY IN THIS REGIN. PATHOLOGY REPORT OF A 0.3 CM IN DIAMETER RUBBERY TAN WHITE RUBBER COATED WIRE. SOUNDS LIKE THE ESOPHAGEAL PROBE. PATIENT WAS AGITATED IN ICU AND MAY HAVE BITTEN THROUGH THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641014 GENERAL PURPOSE TEMPERATURE PROBE CLINICAL ELECTRONIC THERMOMETER FLL DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L 81-020409 223800 00749756046145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other