BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 6570506 · Received May 16, 2017

    Report

    Report Number
    3012307300-2012-01040
    Event Type
    Injury
    Date Received
    May 16, 2017
    Report Date
    January 11, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586028335
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON (B)(6) 2017 THAT THE EVENT HAPPENED "WITHIN THE LAST 10-15 DAYS". THE EXACT DATE IS UNKNOWN. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL RECEIVED THREE CLEO® 90 INFUSION SET WITHOUT ORIGINAL PACKAGING FOR ANALYSIS (ONE WAS RECEIVED IN USED CONDITION, ONE IN UNUSED CONDITION, ONE WHITE CAP WITH ADHESIVE STUCK IN THE TOP). UPON VISUAL EXAMINATION TWO SAMPLES WITH THE ADHESIVE STUCK IN THE WHITE CAP AND ONE DID NOT HAVE THE ADHESIVE NOTED. RELEVANT DOCUMENTS AND OPERATIONS WERE REVIEWED AND DEEMED ADEQUATE. PRODUCTION FLOOR INVENTORY REVIEW WAS CONDUCTED ON (B)(4) UNITS IN ORDER TO INSPECT THE SKIN ADHESIVE WITH NO DISCREPANCIES WERE DETECTED. BASED ON THE EVIDENCE THE COMPLAINT WAS CONFIRMED. HOWEVER, THE ROOT CAUSE IS UNKNOWN. SMITHS MEDICAL RECEIVED THREE CLEO® 90 INFUSION SET FOR ANALYSIS. HOWEVER, IT IS NOT KNOWN AS TO WHICH SET IS RELATED TO WHICH REPORT. TWO REPORTABLE COMPLAINTS (3012307300-2012-01039-240991, 3012307300-2012-01040-240992) AND ONE NON-REPORTABLE ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADHESIVE OF A CLEO® 90 INFUSION SET WAS STUCK TO THE CAP. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE OVER 300MG/DL AT THE TIME OF THE EVENT. PATIENT ADMINISTERED AN INSULIN INJECTION IN ORDER TO ADDRESS THE HIGH BLOOD GLUCOSE LEVELS. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01035, 3012307300-2017-01037, 3012307300-2017-01038, AND 3012307300-2017-01039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350453 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 76X168 10610586028335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention