BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS OPTIMIZED STABILITY VAC PK 6/BX

    MDR report key: 4168871 · Received October 8, 2014

    Report

    Report Number
    1920664-2014-00188
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K63331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE CUSTOMER DISCARDED THE PACKS; THEREFORE THERE WILL BE NO PRODUCT RETURNED FOR EVAL. REPORT 1 OF 15. SEE 1920664-2014-187, 189, 190, 191, 192, 193, 195, 196, 197, 198, 199, 200, AND 201.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED CLOGGED TUBING WITH THIS LOT. THERE WERE NO PT INJURIES OR IMPACT. NO ADDITIONAL DETAILS OR EVENT DATES WERE PROVIDED. THE PRODUCT WAS DISCARDED; THEREFORE THERE WILL BE NO PRODUCT RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631343 STELLARIS OPTIMIZED STABILITY VAC PK 6/BX OPTIMIZED STABILITY DISPOSABLE PACK HQC BAUSCH & LOMB, INC. V1652

    Patients

    Seq Age Sex Outcome Treatment
    1