BEUDAMED
    FDA Adverse Event Other Summary report: N

    NV NITRO PLUM SET

    MDR report key: 144232 · Received January 10, 1998

    Report

    Report Number
    57302-1998-00001
    Event Type
    Other
    Date Received
    January 10, 1998
    Date of Event
    November 26, 1997
    Report Date
    December 8, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED USED SET WAS EXAMINED BY OPTICAL MICROSCOPY AND THE PARTICLE WAS IDENTIFIED AS AN INSECT WHICH WAS THREE MILLIMETERS IN LENGTH. IT IS NOT POSSIBLE TO POSITIVELY DETERMINE IF THE INSECT ORIGINATED IN THE IV SET OR THE ATTACHED BOTTLE, BUT THE PRESENCE OF CONTAMINATION IN OUR PRODUCTS IS RECOGNIZED AS A HIGHLY OBJECTIONABLE CONDITION. OUR MFG SITES UTILIZE SIGNIFICANT RESOURCES TO MINIMIZE THIS TYPE OF DEFECT. A REVIEW OF THE DATA ON FILE INDICATES THIS PROBLEM OCCURS AT A VERY LOW LEVEL BASED UPON THE NUMBER OF UNITS PRODUCED. THE INSECT INHIBITORS AT THE MFG PLANTS ARE ON PREVENTIVE MAINTENANCE PROGRAMS DESIGNED TO ASSURE THEY ARE FUNCTIONING EFFECTIVELY. ADDITIONALLY, MFG AREAS ARE TREATED FOR PEST CONTROL ON A REGULARLY SCHEDULED BASIS. THE WORK ORDERS FOR THE THREE LOTS REPORTED AS POSSIBLY BEING INVOLVED IN THIS INCIDENT WERE REVIEWED BY MFG SITE PERSONNEL. THE REVIEWS REVEALED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THIS TYPE OF PROBLEM. THE SAMPLES TESTED BY QUALITY ASSURANCE PRIOR TO FINAL PRODUCT RELEASE MET SPECIFICATION REQUIREMENTS. A REVIEW OF OUR PRODUCT SURVEILLANCE FILES REVEALED NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN FILED AGAINST THE REPORTED LIST NUMBAER.

    Description of Event or Problem · 1

    RECEIVED REPORT OF A BUG IN IV SET TUBING. A PT WAS ADMITTED AT 0625 ON 11/25/1997. IV NITROGLYCERINE WAS ORDERED AND STARTED AT 1805 ON 11/25, TO BE TITRATED TO EFFECT (DRAWN UP BY ICU STAFF, NOT A PRE-MIX DRIP). THE DRIP HAD BEEN GRAUDUALLY TITRATED UPWARD. NO REPORTED PROBLEMS WITH FLUID FLOW. THE PT WAS TRANSFERRED TO ANOTHER FACILITY ON 11/26/97 AT 1045. NOTED TO HAVE IV FLOW PROBLEMS EN ROUTE TO THE OTHER FACILITY. DISCOVERED BUG IN TUBING WHEN TROUBLESHOOTING. TUBING CHANGED TO SOLVE PROBLEM. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV NITRO PLUM SET ADMINISTRATION SET FPA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other