BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INF. SET CLEO 24" 9MM

    MDR report key: 17595415 · Received August 21, 2023

    Report

    Report Number
    MW5144821
    Event Type
    Injury
    Date Received
    August 21, 2023
    Report Date
    August 17, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SOLICITED CALL FROM PATIENT WHO REPORTED ON (B)(6) HER TUBING BROKE NEAR THE CLAMP SITE. PATIENT ALSO HAD HER PUMP STOP ON (B)(6) BECAUSE HER CATHETER CAME OUT. A NEW SQ SITE WAS PLACED. INFUSION WAS SUCCESSFULLY RESTORED IN BOTH CASES WITHOUT AID. UNKNOWN IF MD IS AWARE. SELF MIX REMUNITY. UNKNOWN IF THE PATIENT STILL HAS THE DEFECTIVE PRODUCT ON HAND, MALFUNCTION DID NOT CAUSE ANY HARM TO THE PATIENT, IT DID NOT OCCUR WHILE IN USE, REPLACEMENT HAS BEEN SHIPPED FOR THE BROKEN TUBING.. REPORTED TO CVS/CAREMARK BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035638 INF. SET CLEO 24" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female PUMP.| REMUNITY.