BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 14601836 · Received June 3, 2022

    Report

    Report Number
    MW5110110
    Event Type
    Injury
    Date Received
    June 3, 2022
    Report Date
    May 16, 2022
    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

    PT AND HUSBAND NEEDING ASSISTANCE WITH BLEEDING SUBCUTANEOUS SITE. PT'S HUSBAND REPORTED THAT A PLASTIC PIECE HAD BROKEN OFF DURING PLACEMENT OF NEW SITE. RECOMMENDED PT CHANGE SITE AND REPLACE BROKEN PIECE. SUPPORTED PT AND HUSBAND AS THEY CHANGED SUBCUTANEOUS SITES. PT'S HUSBAND WAS ABLE TO SUCCESSFULLY CHANGE SITE WITH NO ISSUES. NO OTHER QUESTIONS OR CONCERNS CURRENTLY. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? YES; BLEEDING AT SITE; WAS ANY MEDICAL INTERVENTION PROVIDED? NO; DID WE [MFR] REPLACE THE TUBING? NO; DID HE PT HAVE BACKUP TUBING THEY WERE ABLE TO SWITCH TO? YES; WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811419 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21723124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown