BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2780876 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-01984
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: TWO SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE OBSERVED. FUNCTIONAL TEST WAS PERFORMED. TIP PROTECTORS WERE REMOVED AND A MALE LUER LOCK WAS CONNECTED TO AN EXTENSION SET. THE SETS WERE ABLE TO BE PRIMED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. ADDITIONAL INFORMATION: A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION WAS CORRECTED. THERE WAS PATIENT INVOLVEMENT IN THIS INCIDENT. THE CUSTOMER REPORTED TO BAXTER NEW ZEALAND OF A CLEARLINK LUER ACTIVATED VALVE TO IV ACCESS IN WHICH THE "ACCESS PART OF INJECTION PORT IS DEPRESSED AND CANNOT BE SWABBED." THERE WAS A "FAILURE OF THE INJECTION PORT OF THE LUER ACTIVATED VALVE TO RISE FOR SWABBING. THE VALVES APPEARED TO OPERATE WELL FOR 2 TO 3 DAYS AFTER [THE PATIENT WAS] PUT ON THE PICC LINES AND FAILED AFTER 3 TO 4 DAYS OF USE". THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A CLEARLINK LUER ACTIVATED VALVE TO IV ACCESS IN WHICH THE "ACCESS PART OF INJECTION PORT IS DEPRESSED AND CANNOT BE SWABBED." THE EVENT WAS REPORTED TO HAVE OCCURRED BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 PICC LINE| MEROPENEM AND VANCOMYCIN| BAXTER LARGE VOLUME INFUSOR