BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSUFLON

    MDR report key: 920318 · Received September 5, 2007

    Report

    Report Number
    3003442380-2007-00001
    Event Type
    Injury
    Date Received
    September 5, 2007
    Date of Event
    June 14, 2007
    Report Date
    August 31, 2007
    Manufacturer
    UNOMEDICAL DEVICES SA DE CV
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 6/19/07, THE END-USER CONTACTED INTRA PUMP AND STATED THE FOLLOWING: PT REQUIRING TX LOVENOX WAS SEEN IN CLINIC FOR INSUFLON EDUCATION AND PLACEMENT. PT WENT HOME AND MOTHER CHANGED CATHETER TWICE. THE SECOND CATHETER WAS PLACED IN THE ABDOMINAL AREA MAYBE HITTING A VESSEL OR THE ABDOMINAL/RECTUS MUSCLE. DOSES OF LOVENOX WERE GIVEN AS DIRECTED EVERY 12 HOURS FOR A TOTAL OF 3 DOSES. PT HAD LARGE HEMATOMA, SIGNIFICANT HEMATOCRIT DROP AND HAD TO BE HOSPITALIZED AND TAKEN OFF OF HER ANTICOAGULATION. IN 2007 UNOMEDICAL RECEIVED THE COMPLAINT. UNFORTUNATELY, NO SAMPLES OR INFO REGARDING THE LOT NUMBER WERE RETURNED. UNOMEDICAL A/S HAS CONTACTED INTRA PUMP ON SEVERAL OCCASIONS, REQUESTING THE MISSING INFO. UNOMEDICAL A/S HAS NOT BEEN ABLE TO OBTAIN ANY INFO REGARDING THE ACTUAL OR POSSIBLE LOT NUMBERS OF CATHETERS INVOLVED IN THE REPORTED INCIDENT. THEREFORE, UNOMEDICAL'S QUALITY DEPT HAS NOT BEEN ABLE TO PERFORM ANY TESTING OF NEITHER THE ACTUAL SAMPLE NOR THE RETAINED SAMPLES. SINCE THE LOT NUMBER OF THE SET IS NOT AVAILABLE, BACKTRACKING THE LOT NUMBER FOR REVIEW OF THE HISTORY RECORDS OF THE LOT. IF INFO ABOUT THE LOT NUMBER ARE MADE AVAILABLE, TESTING WILL BE PERFORMED AND IF APPROPRIATE, A FOLLOW UP REPORT WILL BE SUBMITTED. CONCLUSION: BASED ON THE INFO ABOVE AND THE FACT THAT NEITHER THE USED SAMPLE NOR THE LOT NUMBER INVOLVED IN THIS COMPLAINT WERE RETURNED FOR ANALYSIS WE ARE UNABLE TO CONFIRM ANY PRODUCT FAILURE. UNOMEDICAL A/S HAS REVIEWED THE CASE INFO, AND IT IS OUR UNDERSTANDING THAT THE INCIDENT WAS RELATED IN PART TO THE PLACEMENT OF THE CATHETER AND IN PART TO THE PT'S REQUIREMENT FOR ANTICOAGULATION. THEREFORE NORMAL PROCEDURE WOULD BE TO REPORT THE INCIDENT BY ASR TO THE FOOD AND DRUG ADMINISTRATION.

    Description of Event or Problem · 1

    PT REQUIRING TX LOVENOX WAS SEEN IN CLINIC FOR INSUFLON EDUCATION AND PLACEMENT. PT WENT HOME AND MOTHER CHANGED CATHETER. THE SECOND CATHETER WAS PLACED IN THE ABDOMINAL AREA MAYBE HITTING A VESSEL OR THE ABDOMINAL/RECTUS MUSCLE. DOSES OF LOVENOX WERE GIVEN AS DIRECTED EVERY 12 HOURS FOR A TOTAL OF 3 DOSES. PT HAD LARGE HEMATOMA, SIGNIFICANT HEMATOCRIT DROP AND HAD TO BE HOSPITALIZED AND TAKEN OFF OF HER ANTICOAGULATION. FROM THE NURSE: "IT WAS FLOOR STOCK SO I MAY HAVE TO GIVE A FEW DIFFERENT LOT NUMBERS. LOT NUMBERS OR ACTUAL SAMPLE CAN NOT BE DETERMINED AND ARE NOT AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFLON INDWELLING CANNULA FOZ UNOMEDICAL DEVICES SA DE CV 98-000-2612 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening| R