BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2944444 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02988
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. ONE ACTUAL DEFECTIVE SAMPLE WAS RETURNED AT THE PLANT FOR EVALUATION. UPON VISUAL INSPECTION, AN INVERTED SEPTUM WAS OBSERVED AT THE MALE LUER LOCK. NO FURTHER TESTING WAS PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS REPORTED THAT THE DEVICE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE EVALUATION OF IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE CUSTOMER OBSERVED A LEAK FROM THE INVERTED SEPTUM OF AN UNUSED INJECTION SITE ON A INTERLINK NON-DEHP T-CONNECTOR EXTENSION SET. THIS OCCURRED ON THE 10TH DAY OF USE OF THE SET. THE SET WAS CONNECTED TO A PERCUTANEOUS CENTRAL VENOUS CATHETER, A THREADED LOCK CANNULA AND AN ADMINISTRATION SET. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48108 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 PERCUTANEOUS CENTRAL VENOUS CATHETER| ADMINISTRATION SET| THREADED LOCK CANNULA