BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000105-1999-00001

    MDR report key: 257426 · Received December 22, 1999

    Report

    Report Number
    6000105-1999-00001
    Event Type
    Malfunction
    Date Received
    December 22, 1999
    Date of Event
    November 1, 1999
    Report Date
    December 17, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    GENERAL REPORT OF DISCONNECTION OF IV TUBING SETS. REPORT REC'D FROM ABBOTT INTERNATIONAL AFFILIATE, ABBOTT FRANCE, STATES "DISCONNECTION OF DIFFERENT PARTS OF THE SETS, PROBABLY BY LACK OF SOLVENT AT THE LEVEL OF THE SIGHT CHAMBER AND THE Y INJECTION SITE." NO FURTHER INFO IS AVAILABLE. ADD'L INFO HAS BEEN REQUESTED, BUT NO INFO HAS BEEN REC'D.

    Description of Event or Problem · 1

    A F/U REPORT WAS RECEIVED FROM ABBOTT INT'L AFFILIATE, ABBOTT, FRANCE, WHICH STATES "MOST OF THE TIME THE USERS NOTED THE DISCONNECTIONS WHEN THEY UNWRAPPED THE PACKAGING OR DURING PRIMING. IN 4 CASES IT OCCURRED DURING THE INFUSION. NO HARMFUL CONSEQUENCES FOR THE PTS. NO ADD'L INFO AVAILABLE".

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other