BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDLINE CATHETERIZATION KIT: 4 FR X 8"

    MDR report key: 4863819 · Received June 23, 2015

    Report

    Report Number
    1036844-2015-00270
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K963257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EXAMINATION OF A RETURNED PRODUCT SAMPLE. THE CUSTOMER PROVIDED A PEEL-AWAY SHEATH WITH ONE SIDE OF THE HUB DETACHED. NO PART OF THE SHEATH BODY REMAINED IN THE DETACHED SIDE OF THE HUB. THE SHEATH BODY WAS SPLIT ALONG THE TEAR MARKS ON BOTH SIDES. A REVIEW OF MANUFACTURING RECORDS DID RETURN A RELEVANT FINDING. THEREFORE, THE PROBABLE CAUSE OF THIS ISSUE IS MANUFACTURING RELATED. FURTHER INVESTIGATION HAS BEEN INITIATED WITH THE MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INSERTION THE SHEATH INTRODUCER TABS SEPARATED FROM THE SHEATH BODY. THE CLINICIAN WAS ABLE TO GRAB THE SHEATH BODY AND PULL IT OUT. THE CATHETER REMAINED IN POSITION. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407282 MIDLINE CATHETERIZATION KIT: 4 FR X 8" MIDLINE CATHETERS LJS ARROW INTERNATIONAL INC. 23F15A0149

    Patients

    Seq Age Sex Outcome Treatment
    1