BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1053074 · Received May 28, 2008

    Report

    Report Number
    3002859087-2008-00019
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Report Date
    May 5, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 5/28/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. BARBARA IS UNSURE IF THE PRODUCT IS OURS, STATES THAT THEIR FACILITY ALSO USES OTHER MFR'S HEPARIN. OUR INFO WAS PROVIDED TO HER BY THE WAREHOUSE THAT THEY PURCHASE FROM, AND IS CURRENTLY WHAT WAS ON THE SHELF. BARBARA DOES NOT HAVE THE PRODUCT ID, STATES IT IS A 5ML SYRINGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD AN ISSUE WITH A PREFILLED SYRINGE. BARBARA AGUE, PHARMACIST, REPORTS THAT A PT CONTACTED THE PHARMACY STATING THAT SHE HAS HER MEDIPORT FLUSHED MONTHLY AND, OVER THE PAST YEAR, TWO WEEKS AFTER RECEIVING THE FLUSH SHE HAS ABDOMINAL PAIN AND NAUSEA. PT REPORTED TO BARBARA THAT SHE HAS BEEN HOSPITALIZED FOR PANCREATITIS, BUT HAS HAD NO ENZYME ELEVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PREFILL PREFILL SYRINGE NZW TYCO HEALTHCARE/KENDALL UNK PREFILL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK