BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE LUMEN PERIPHERALLY INSERTED CENTER VENOUS CATHETER SET

    MDR report key: 3800289 · Received May 1, 2014

    Report

    Report Number
    1820334-2014-00186
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COOK, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION - UNK AS LOT IS UNK. CATHETER DAMAGE IS LABELED IN THE IFU. UNK AS LOT IS UNK. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT UNDERWENT PICC INSERTION FOR ANTIBIOTICS THROUGH THE PICC LINE, AS PER IFU. DURING COURSE OF TREATMENT A CRACK/SPLIT OCCURRED NEAR THE SUTURE WING PICC REMOVED AND NEW ONE INSERTED. NO ADVERSE EFFECTS TO THE PT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261002 SINGLE LUMEN PERIPHERALLY INSERTED CENTER VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention