BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.6F X 50CM DUAL VASCU-PICC

    MDR report key: 14242544 · Received April 28, 2022

    Report

    Report Number
    2518902-2022-00031
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 22, 2022
    Report Date
    August 11, 2022
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJS
    UDI-DI
    00884908146509
    PMA / PMN Number
    K102966
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED. CURRENTLY WAITING FOR ADDITIONAL INFORMATION AND NOTIFICATION IF THE DEVICE WILL BE RETURNED FOR EVALUATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THE PICCS WERE SECURED TO THE PATIENTS USING A DEVICE CALLED A SECURACATH WHICH IS MANUFACTURED BY INTERRAD MEDICAL, INC. THE CATHETERS WERE INITIALLY SENT TO A SECURACATH REPRESENTATIVE FOR A REVIEW. ONCE THEIR INVESTIGATION WAS COMPLETED THE PICCS WERE SENT TO MEDCOMP (WITHOUT THE SECURACATH DEVICES THAT WERE USED WITH THE PICCS). AN UNUSED SAMPLE WAS PROVIDED. MEDCOMP ENGINEERING DEPARTMENT WAS ASKED TO REVIEW THE PICCS. THE FIRST SAMPLE WAS PINCHED. THE LUMEN COLLAPSED WHICH SHOULD HAVE RESULTED IN POOR FLOW. IT APPEARS THAT THERE IS A STRESS POINT WHERE THE LUMEN EXITS THE SECURACATH, AND THAT ANY MOVEMENT WOULD PUT STRESS ON THE SAME POINT UNTIL POTENTIALLY BREAKING. THIS IN ADDITION TO BEING PINCHED PROBABLY RESULTED IN THE BREAK DUE TO FATIGUE. A PICTURE PULLED FROM THE INTERNET SHOWED HOW THE DISTANCE BETWEEN THE HUB AND SECURACATH ALIGN WITH WHERE THE BREAK WAS ON THE 2.6F PICC. THE SECOND SAMPLE WAS NOT PINCHED BUT LOOKS LIKE IT DID BEND LONG ENOUGH TO FATIGUE AND BREAK WHERE IT EXITS THE BACKSIDE OF THE SECURACATH. THE LUMEN HAS AN IRREGULAR BREAK AND CRACKS. IN ADDITION, IT APPEARS THE LUMEN EXITING THE HUB IS ELONGATED AS IF IT WAS PULLED ON. THE LUMEN WAS REDUCED IN SIZE (DIAMETER) IN ALL AXES. IT IS IMPOSSIBLE TO DETERMINE WITH CERTAINTY THAT THE SECURACATH ITSELF CAUSED THE FAILURES. IT COULD HAVE BEEN A RESULT OF ACTIVE PATIENTS, POORLY SECURED CATHETERS, OR A COMBINATION OF THEM ALL. IT IS BELIEVED THAT THE CATHETER FAILED FOR REASONS OTHER THAN DESIGN OR MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PICC BROKE AT THE DISTAL END OF THE HUB. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57960 2.6F X 50CM DUAL VASCU-PICC VASCU-PICC LJS MEDICAL COMPONENTS, INC. MD17012600 MQAV360 00884908146509

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Required Intervention SECUACATH BY INERRAD MEDICAL INC.