BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3914059 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21532
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK CATHETER EXTENSION SET LEAKED FROM THE INJECTION SITE DURING INFUSION OF LEXISCAN. THE REPORTER STATED ¿THE FIRST INFUSION OF THE DRUG GOES INTO THE PATIENT WITHOUT AN ISSUE, THE LINE IS THEN FLUSHED, AND WHEN A SECOND DOSE IS INJECTED¿ THE LEAK WAS NOTED FROM THE INJECTION SITE. THE CUSTOMER STATED THAT AN UNKNOWN PRIMARY SET IS INSERTED INTO THE PATIENT AND THE EXTENSION SET IS ATTACHED AND FLUSHED WITH SALINE USING A BD BLUNT PLASTIC CANNULA. THE DRUG IS THEN INJECTED USING A 20 GAUGE LYNCH NEEDLE. THE CUSTOMER STATED THAT THE LEAK OCCURS WHEN THE LYNCH NEEDLE IS REMOVED FROM THE SET AND FLUID STARTS TO COME OUT THROUGH THE INJECTION SITE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391271 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 LEXISCAN| SALINE SOLUTION| BD BLUNT PLASTIC CANNULA| 20 GAUGE LYNCH NEEDLE