BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3760063 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12696
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CAUSE OF THE COLLAPSED SEPTUM COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE ARRIVED OUT OF THE POUCH. VISUAL INSPECTION SHOWED THAT THE SEPTUM WAS INVERTED. THE SAGE HEIGHT WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE SEPTUM WAS THEN REMOVED FROM THE Y SITE HOUSING AND VISUALLY INSPECTED UNDER A MICROSCOPE. IT WAS FOUND THAT THE CENTER SLIT WAS PRESENT AND COMPLETELY THROUGH THE SEPTUM. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEFECT AND THE CONDITION THAT THE SAMPLE WAS RETUNED IN. THE REPORTED CONDITION WAS CONFIRMED. NO OTHER OBVIOUS DEFECTS WERE FOUND. NO FURTHER TESTING WAS PERFORMED. A BATCH REVIEW WILL BE PERFORMED.  IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK INJECTION SITE LEAKED. THIS OCCURRED DURING A PATIENT INFUSION. THE REPORTER STATED THAT THE DEVICE WAS BEING USED WITH AN UNKNOWN BLUNT TIP METAL NEEDLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237598 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR13K06034

    Patients

    Seq Age Sex Outcome Treatment
    1