BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2821756 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04221
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED CONDITION OF A SECONDARY MEDICATION SET THAT WAS ALLEGED WITH A BENT SPIKE WAS CONFIRMED DURING PRODUCT EVALUATION; HOWEVER NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER WAS UNAVAILABLE. SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE THAT ONE MEDICATION SET, CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR, WAS ALLEGED TO HAVE A SPIKE THAT WAS BENT. THIS WAS OBSERVED WHEN ACCESSING A "CHURCHILL" BRAND 500ML EMPTY BAG (ASSOCIATED WITH PRODUCT CODE "100701D"). THE REPORTER INDICATED THAT THE THE USER WAS UNABLE TO SPIKE THE BAG DUE TO THE BENT SPIKE. THIS CONDITION WAS OBSERVED PRIOR TO COMPOUNDING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THE SAMPLE IS AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1