BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTRAL MARK CATHETER

    MDR report key: 61687 · Received January 13, 1997

    Report

    Report Number
    MW1010548
    Event Type
    Other
    Date Received
    January 13, 1997
    Date of Event
    January 9, 1997
    Report Date
    January 10, 1997
    Manufacturer
    MENLO CARE, INC.
    Product Code
    DQO
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS GETTING VANCOMYCIN 1GM IV Q 12 HRS IN THE HOSP. PT WAS TRANSFERRED TO ECF (EXTENDED CARE FACILITY) WITHOUT THE IV LINE. CATHETER WAS INSERTED VIA NUMBER 17 INTRODUCER PER LEFT MEDIAN CUBITAL BASILIC. IMMEDIATELY AFTER CATHETER FEEDING, PT BECAME VERY FLUSHED, TENSING HIS UPPER EXTREMITIES TOWARDS MIDLINE AND WAS ABLE TO RESPOND "AM SCARED." EPISODE SUBSIDED AFTER APPROX 10 SECS, PT'S COLOR RETURNED TO NORMAL AND PT DENIED FEELING ILL AND HAVING BRONCHOSPASM. CATHETER WAS THEN FLUSHED WITHOUT DIFFICULTY WITH 10 CC OF NORMAL SALINE FOLLOWED BY 3CC OF HEPARIN 100 UNITS PER ML. VITAL SIGNS BEFORE PICC INSERTION WERE: TEMP 98.3, PULSE 80, RESPIRATION 20. BP 134/74. AFTER PICC PLACEMENT; VITAL SIGNS WERE 98.2, 74 PULSE, RESPIRATION 32 AND BP WAS 124/70.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL MARK CATHETER CATHETER DQO MENLO CARE, INC. UNK 51106

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other