BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2942453 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02884
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 16, 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). DEVICE AVAILABLE FOR EVALUATION. IF ADDITIONAL 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. ONE ACTUAL DEFECTIVE SAMPLE WAS RETURNED TO THE PLANT FOR EVALUATION. THE UNIT WAS VISUALLY CHECKED .THE VISUAL INSPECTION REVEALED THE TUBING WAS TORN AND SEPARATED FROM THE MALE LUER LOCK OF THE SET. THE TUBING WAS TORN AT THE TUBING INSERTION PORT AND TUBING INSIDE THE MALE LUER LOCK STILL REMAIN BONDED CORRECTLY. NO FURTHER TESTING WAS PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE TUBING SEPARATED FROM THE T-CONNECTOR. THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT INJURY. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46036 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12A10037

    Patients

    Seq Age Sex Outcome Treatment
    1