BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3874491 · Received June 16, 2014

    Report

    Report Number
    1416980-2014-19119
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K123868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS OCCURRED AFTER AN INTRAVENOUS CONTRAST INJECTION USING A POWER INJECTOR (NON-BAXTER PRODUCT) SET AT 1 TO 5 CC/SECOND. THE CAUSE OF THE SLIT WAS DETERMINED TO BE INAPPROPRIATE USE OF A POWER INJECTOR WITH THE SET. A LABELING REVIEW WAS CONDUCTED, AND THIS PRODUCT WAS DETERMINED TO BE UNAPPROVED FOR USE WITH POWER INJECTORS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION BY THE NAKED EYE VERIFIED THE TUBING HAD BEEN CRIMPED / CLOSED OFF AT THE LUER ACTIVATED VALVE CLOSEST TO THE MALE LUER ADAPTER. NEAR THE CRIMP, THE TUBING HAD EXPANDED AND HAD A SLIT IN IT APPROXIMATELY ONE HALF INCH LONG. THE REPORTED PROBLEM WAS VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK CONTINU-FLO SOLUTION SET TUBING SPLIT OPEN DURING FLUSHING OF THE LINE. THE SPLIT WAS FURTHER DESCRIBED AS BEING LOCATED ABOVE THE FIRST PORT (DISTAL END). THE FLUSH WAS DONE WITH A MANUAL SYRINGE. THERE WAS A CLAMP PLACED ON THE TUBE AT THE LOCATION WHERE THE TUBING SPLIT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352503 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDRAD POWER INJECTOR