BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2168052 · Received July 19, 2011

    Report

    Report Number
    6000001-2011-13082
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT WHEN THE INTERLINK T-CONNECTOR EXTENSION SET WAS CONNECTED TO THE IV SITE, THE HUB WAS SECURE AND TIGHT. WHEN IT WAS FLUSHED WITH A BD 3ML POSIFLOW PRE-FILLED NORMAL SALINE SYRINGE, SALINE LEAKED FROM THE HUB OF THE T-CONNECTOR, THEN LESS THAN 0.25ML OF BLOOD LEAKED OUT AND FLUSHING STOPPED. THE LEAK LOOKED LIKE IT WAS ABOVE THE SWIVEL, NOT LEAKING AROUND THE HUB ITSELF. THE MEDICAL PRACTITIONER ENCOUNTERED THIS ISSUE A FEW DAYS AGO AND THOUGHT IT WAS JUST ATTRIBUTED TO THE HUB NOT BEING PROPERLY TIGHTENED ONTO THE IV CATHETER. A NEW T-CONNECTOR WAS USED, WITHOUT ISSUE. THE T-CONNECTOR CAME FROM THE IV START KIT. THE CONDITION OCCURRED DURING USE ON A (B)(6) INFANT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 BD 3ML POSIFLOW PRE-FILLED NORMAL SALINE