BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CATHETER

    MDR report key: 1671784 · Received April 26, 2010

    Report

    Report Number
    1718873-2010-00003
    Event Type
    Malfunction
    Date Received
    April 26, 2010
    Date of Event
    April 3, 2010
    Report Date
    April 6, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE CATHETER WAS RECEIVED THE TUBING HAD BEEN SEVERED JUST BELOW THE 14 CM MARK. THE CATHETER HAD THE APPEARANCE THAT IT HAD BEEN DAMAGED, THEN PULLED APART DURING THE CATHETER REMOVAL. AN UNDAMAGED SEGMENT OF THE CATHETER TUBING WAS PULL TESTED AT UTMD. THE TENSILE FORCE AND THE TUBING ELONGATION WERE WITHIN SPECIFICATION. PER THE NICU EDUCATOR AT THE HOSPITAL THE CATHETER BROKE DURING REMOVAL AFTER IT HAD BEEN IN USE FOR 36 HOURS. THERE WAS NO LONGER TERM PT IMPACT. APPEARS CATHETER WAS DAMAGED PRIOR TO THE SEVER NEAR SITE OF THE SUTURES. CATHETER BROKE NEAR SUTURES.

    Description of Event or Problem · 1

    THE CATHETER BROKE NEAR THE LOCATION OF THE SUTURES AS IT WAS BEING REMOVED FROM THE UMBILICUS AFTER INDWELLING FOR 36 HOURS. A BLOOD TRANSFUSION WAS ADMINISTERED TO REPLACE 10 CC OF BLOOD LOSS DURING THE REMOVAL OF THE DISTAL END OF THE UAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL CATHETER UMBILI-CATH FOS UTAH MEDICAL PRODUCTS, INC. NA 1090935

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other