BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDLINE CATHETERIZATION KIT: 4 FR X 8IN

    MDR report key: 3202100 · Received June 27, 2013

    Report

    Report Number
    1036844-2013-00221
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LJS
    PMA / PMN Number
    963257
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO PEEL THE SHEATH APART AFTER THE MIDLINE CATHETER WAS INSERTED THE ORANGE HANDLES ON THE TOP PART OF THE SHEATH RIPPED APART FROM THE REST OF THE SHEATH. THIS OCCURRED IN THE SPECIAL PROCEDURES ROOM AND THE CATHETER WAS BEING INSERTED INTO THE CEPHALIC VEIN OF THE LEFT ARM. THE INSERTING NURSE WAS ABLE TO REMOVE WHAT WAS LEFT OF THE SHEATH FROM THE PT'S INSERTION SITE USING FORCEPS. THE CATHETER WAS PLACED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293001 MIDLINE CATHETERIZATION KIT: 4 FR X 8IN MIDLINE CATHETERS LJS ARROW INTERNATIONAL INC RF3026419

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK