BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 1963644 · Received December 21, 2010

    Report

    Report Number
    3006425876-2010-00094
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K970864
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE WAS NOT PROTECTED WITH A CAP, THE USER "PRICKED" THEMSELVES AND THERE WAS A RISK THAT THE TRAY WAS DAMAGED. ADD'L INFO WAS RECEIVED FROM TELEFLEX (B)(4) ON (B)(6) 2010, THAT CLARIFIED THE USER IS FINE; HE DID NOT REQUIRE TREATMENT, NO CONSEQUENCE. THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN THERAPY REPORTED. NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 12 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. ZF9035843

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK