BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL LINE SET 2.5F, 22G, 5CM

    MDR report key: 7147574 · Received December 26, 2017

    Report

    Report Number
    MW5074233
    Event Type
    Injury
    Date Received
    December 26, 2017
    Date of Event
    December 19, 2017
    Report Date
    December 22, 2017
    Manufacturer
    COOK MEDICAL
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING THE CATHETER, A PORTION BROKE OFF, WAS RETAINED AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL. THIS WAS A SPONTANEOUS SEPARATION, USER ERROR WAS RULED OUT. SIMILAR PRODUCTS WERE INVOLVED IN A RECALL OF SIMILAR NATURE IN 2016. EFFECTED LOT NUMBERS 5895605, 6191185. DATES OF USE: (B)(6) 2017. DIAGNOSIS: CONGENITAL HEART DISEASE. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924983 ARTERIAL LINE SET 2.5F, 22G, 5CM CATHETER, PERCUTANEOUS DQY COOK MEDICAL G02930 8254490

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention