BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2110335 · Received June 1, 2011

    Report

    Report Number
    6000001-2011-06874
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A CUSTOMER SENT IN ONE COMPANION UNUSED SAMPLE FOR AN EVALUATION. A VISUAL INSPECTION SHOWED THAT THE SPIKE TIP WAS BENT. THE CAUSE OF THIS CONDITION REMAINS UNIDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE HAS BEEN SENT IN FOR AN EVALUATION. ONCE THE SAMPLE IS EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO: THE TIP OF THE SPIKE BENT WHILE ATTEMPTING TO SPIKE AN UNKNOWN BAXTER IV MEDICATION BAG.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A CLEARLINK SET IN WHICH THE END OF THE SPIKE WAS BENT. THE NURSE WAS ATTEMPTING TO SPIKE A SECONDARY BAG WITH AN UNKNOWN ANTIBIOTIC. THIS CONDITION OCCURRED BEFORE USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE CUSTOMER DID MAKE A MEDWATCH REPORT FOR THIS CONDITION, (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR11B21041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY BAG| UNK ANTIBIOTIC