BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI PICCKIT: 2-L 5 FR X 50 CM WITH PRELOADED S

    MDR report key: 3960036 · Received May 29, 2014

    Report

    Report Number
    1036844-2014-00228
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K121941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN HAS EXPERIENCED DIFFICULTY WHEN ADVANCING THE PEEL AWAY SHEATH AND DILATOR OVER THE SPRING WIRE GUIDE INTO THE PATIENT IN BOTH THE 40CM AND 50CM KITS. OVER THE PAST MONTH THEY HAVE ENCOUNTERED A GREAT DEAL OF RESISTANCE WHERE THE TIP OF THE SHEATH BECOMES DAMAGED. AT WHICH TIME THEY OPEN A SELDINGER CONVERSION KIT FOR A NEW SHEATH/DILATOR, MAKE A SKIN NICK WITH THE SCALPEL, AND ADVANCE THE ASSEMBLY INTO PLACE. THERE HAVE BEEN NO DELAYS IN TREATMENT AND NO PATIENT DEATHS OR COMPLICATIONS REPORTED. SEE MDR 1036844-2014-00227 FOR THE SAME ISSUE WITH THE 40CM KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315575 PI PICCKIT: 2-L 5 FR X 50 CM WITH PRELOADED S NONE LJS ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1