BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2921773 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01368
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. ACTUAL SAMPLE, WITHOUT POUCH, WAS AVAILABLE AT THE PLANT FOR EVALUATION. UPON VISUAL INSPECTION, THE VENTED MALE LUER TIP PROTECTOR WAS MISSING AND THE INTERLINK INJECTION SITE WAS SEPARATED FROM ADAPTER, FEMALE LUER LOCK. IN ADDITION, THE STEM OF THE INTERLINK INJECTION SITE SUB-ASSEMBLY FOUND TO BE BROKEN OR FRACTURED. THE BROKEN PIECE OF STEM WAS REMAINED IN THE ADAPTER, FEMALE LUER LOCK. NO OTHER TEST WAS PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT A CATHETER EXTENSION SET, WITH LUER SLIP, WAS OBSERVED TO HAVE A LEAK AT THE INJECTION SITE AND TUBING JUNCTION. THE REPORTED CONDITION OCCURRED DURING PATIENT USE. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27693 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1