BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4182369 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36350
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING FOLLOW-UP WITH THE REPORTER, THEY STATED THAT THIS OCCURRED WHEN THE DEVICE WAS BEING DISCONNECTED FROM THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE MALE LUER REPORTEDLY DISINTEGRATED, AND THE LEAK THEN OCCURRED. IT WAS ALSO REPORTED THAT A NON-BAXTER ALCOHOL CAP AND ALCOHOL PREP PAD WERE USED WITH THE DEVICE PRIOR TO THE EVENT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANTI-SIPHON COMBINATION SET LEAKED FROM ITS TUBING. THE STEP OF SETUP OR THERAPY DURING WHICH THIS OCCURRED IS UNKNOWN. PATIENT INVOLVEMENT IS UNKNOWN, THOUGH THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661440 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 CUROS CAP, COVIDIEN ALCOHOL PAD