BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1021343-2001-00012

    MDR report key: 357522 · Received October 19, 2001

    Report

    Report Number
    1021343-2001-00012
    Event Type
    Malfunction
    Date Received
    October 19, 2001
    Date of Event
    September 1, 2001
    Report Date
    September 18, 2001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    REPORT #2 OF 2 OF A GENERAL REPORT RECEIVED OF UNDOCUMENTED INCIDENCES OF IV ACCESS LOSS DUE TO THE SYRINGE STICKING WHILE FLUSHING. IN A TOTAL OF 5 TO 6 ADULT PT'S AND 2 PEDIATRIC PT'S, THE CUSTOMER REPORTED THAT WHEN USING BOTH 5 AND 10CC SYRINGES TO FLUSH AN IV ACCESS, THE SYRINGE PLUNGERS WOULD STICK. THE CUSTOMER COULD NOT RECALL WHICH INCIDENCES INVOLVED THE 5CC SYRINGES AND WHICH INVOLVED THE 10CC SYRINGES. THIS LED TO THE LOSS OF THE IV SITES DUE TO THE ADDITIONAL PRESSURE REQUIRED TO ADMINISTER THE FLUSH SOLUTION. THE REPORTER STATED THAT ALL IV'S WERE ABLE TO BE RESTARTED WITHOUT PROBLEM. THERE WAS NO REPORT OF ANY ADVERSE PT EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other