BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

    MDR report key: 10059628 · Received May 14, 2020

    Report

    Report Number
    1625425-2020-00322
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 20, 2020
    Report Date
    May 14, 2020
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209750
    PMA / PMN Number
    K972262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE DEVICE WAS RETURNED AND EVALUATED. THE PICC LINE WAS FOUND TO BE BROKEN APPROXIMATELY 2- 3 MM FROM THE SECUREMENT DISC. BASED ON THE INSPECTION OF THE BREAKAGE SITE, THE MOST PROBABLE CAUSE OF THE BREAK MAY BE DUE TO PATIENT ACTIVITY OR MOVEMENT, OR EXCESSIVE TENSILE/PULLING FORCE USED DURING USE.

    Description of Event or Problem · 1

    24HR F/U PICC X-RAY DONE AT 2211. AFTER REVIEWING, NNP PLACED ORDER TO PULL PICC BACK 8CM TO NON-CENTRAL MID-HUMERUS LOCATION. INFANT WAS SWADDLED, GIVEN COMFORT MEASURES, AND PICC WAS PULLED OUT 8CM IN STERILE FASHION. X-RAY REPEATED TO VERIFY PLACEMENT. NNP REVIEWED AND APPROVED USE. INFANT TOLERATED PROCEDURE WELL. (B)(6), RN CALLED TO BEDSIDE BY CHARGE NURSE WHO REPORTED THAT INFANT'S PICC LINE WAS FOUND TO BE BROKEN BEYOND THE DISC AT THE START OF THE CATHETER. THERE WAS NO LEAKING OF IV FLUID NOTED AROUND THE SITE. THE REMAINING CATHETER WAS EASILY REMOVED FROM THE BABY'S ARM AND THE ENTIRE CATHETER LENGTH WAS COUNTED AS REMOVED. (B)(6), RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518334 FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM FIRST PICC LJS ARGON MEDICAL DEVICES 384232 11268972 00886333209750

    Patients

    Seq Age Sex Outcome Treatment
    1