BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 23905601 · Received December 29, 2025

    Report

    Report Number
    3012307300-2025-13791
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 29, 2025
    Manufacturer
    SET, ADMINISTRATION, INTRAVASCULAR
    Product Code
    FPA
    UDI-DI
    30610586028339
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO PRODUCT WAS RECEIVED FOR ANALYSIS. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE PRODUCT A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE INFUSION SET WAS CRACKED DURING TRAINING AND WAS DISPOSED OF AT THAT TIME. ANOTHER INFUSION SET LEAKED AT THE ARM SITE THIS PAST WEEK AND HAD TO BE REPLACED. ADDITIONALLY, ONE INFUSION SET TRIGGERED REPEATED ¿LINE BLOCKED¿ ALARMS, WHICH WERE RESOLVED BY CHANGING THE SITE TWO WEEKS AGO. THE PERSON WITH DIABETES (PWD) DID NOT RETAIN THE DEFECTIVE INFUSION SETS AND EXPRESSED CONCERN ABOUT RUNNING OUT OF INFUSION SETS. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THE OPERATOR OF THE DEVICE WAS THE LAY USER OR PATIENT. THERE WAS NO PATIENT INJURY. PATIENT IS A WHITE, NON-HISPANIC FEMALE, BORN ON (B)(6)1998 AND WEIGHING 230 LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505787 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SET, ADMINISTRATION, INTRAVASCULAR 4461417 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female