BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3080915 · Received April 26, 2013

    Report

    Report Number
    2183996-2013-00746
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 13, 2013
    Report Date
    May 3, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO MATERIAL WAS RETURNED FROM THE CUSTOMER AND THE LOT NUMBER IS UNKNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE, THE COMPLAINT CANNOT BE VERIFIED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED HER INFUSION SITE HAS BEEN "RED, WHITE, AND PUS-LIKE WITH BLOOD EMERGING FROM THE SITE" SINCE SHE REMOVED AN INFUSION HEADSET ON (B)(6) 2013. SHE WILL SEE HER DOCTOR ON (B)(6) 2013 FOR THIS CONCERN AND HAS BEEN TREATING THE SITE BY APPLYING OINTMENT AND A COOL WASHCLOTH. SHE WAS UNABLE TO PROVIDE THE LOT NUMBER AND EXPIRATION DATE, AND THE INFUSION SET WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. FOLLOW-UP WAS COMPLETED WITH THE PATIENT ON (B)(6) 2013. SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH AN INFECTION AT HER INFUSION SITE. HER DOCTOR PRESCRIBED AN ANTIBIOTIC FOR 10 DAYS, AND SHE WILL RETURN FOR A ROUTINE APPOINTMENT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182006 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR Required Intervention LISINOPRIL HYDROCHLOROTHIAZIDE| ASPIRIN| NOVALOG| METPHORMIN| LIPITOR