BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KWIK VIAL, 15ML, CASE (30015)

    MDR report key: 3567504 · Received January 10, 2014

    Report

    Report Number
    1419106-2014-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. NO PRODUCT WAS RETURNED FOR AN EVALUATION. NO EVALUATION PERFORMED AS THERE WERE DEVICES RETURNED. ON (B)(4) 2013, BAXTER (B)(4) WAS NOTIFIED THROUGH AN EMAIL FROM BAXTER HEALTHCARE CORPORATION, REGARDING MEDWATCH 5032498. MEDWATCH 5032498 REPORTED LEAKING KWIK VIALS. NO PATIENT INVOLVEMENT OR OPERATOR INJURY WAS REPORTED. A FOLLOW UP WITH THE CUSTOMER INDICATED THAT THERE ARE NO SAMPLES AVAILABLE TO BE RETURNED FOR AN EVALUATION. THE CUSTOMER HAD NOTICED THAT AT THE TIME OF PRODUCTION, THE SEALS WERE NOT SEALED AROUND THE RIM. THERE ARE NO SAMPLES AVAILABLE FOR AN EVALUATION. THE SUPPLIER OF THESE COMPONENTS HAS BEEN NOTIFIED OF THE ISSUE AND HAS IMPLEMENTED CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF THIS ISSUE. OUR RISK ASSESSMENT OF THESE REPORTED ISSUES SHOW THAT THE POTENTIAL OF PATIENT HARM IS SUFFICIENTLY LOW DUE TO THE FOLLOWING RISK CONTROL MEASURES: 1. THE SUPPLIER WAS NOTIFIED AND DETERMINED THAT MINIMAL IMPACT TO PRODUCTIVITY OR CUSTOMER PERCEPTION, RISK TO SAFETY AND EFFICIENCY. 2. THE SUPPLIER WILL ADD AN INSPECTION TO THE CONTROL PLAN FOR THE KNIT LINE. BASED ON AN EVALUATION OF THE PRODUCT RISK MANAGEMENT FILES FOR THESE KWIK VIALS, THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED FOR THE DEVICE. DEVICE NOT AVAILABLE

    Description of Event or Problem · 1

    ON (B)(6) 2013, BAXTER (B)(4) WAS NOTIFIED THROUGH AN EMAIL FROM BAXTER HEALTHCARE CORPORATION, REGARDING MEDWATCH 5032498. MEDWATCH 5032498 REPORTED LEAKING KWIK VIALS. NO PATIENT INVOLVEMENT OR OPERATOR INJURY WAS REPORTED. A FOLLOW UP WITH THE CUSTOMER INDICATED THAT THERE ARE NO SAMPLES AVAILABLE FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19301 KWIK VIAL, 15ML, CASE (30015) KWIK VIAL, 15ML, CASE (30015) KAI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1