BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INTRACATH IV CATHETER

    MDR report key: 2062767 · Received April 8, 2011

    Report

    Report Number
    9610048-2011-00004
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    November 27, 2008
    Report Date
    December 1, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO YEAR RETROSPECTIVE REVIEW OF SIMILAR PRODUCTS SOLD INTO THE US THAT ARE MFG AND SOLD BY BD OUTSIDE OF THE US. (B)(4) - RESULTS: THE SAMPLE WAS NOT AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7277819. CONCLUSIONS: SINCE THE SAMPLE WAS NOT RETURNED FOR EVAL, WE WERE UNABLE TO IDENTIFY A ROOT CAUSE FOR THE PROBLEM ENCOUNTERED. (B)(4).

    Description of Event or Problem · 1

    THE DR ATTEMPTED TO INSERT/POSITION THE CATHETER THREE TIME INTO THE JUGULAR VEIN, AND EACH TIME, THE GUIDEWIRE WOULD NOT PASS THROUGH THE CATHETER AND THE CATHETER WAS TRAPPED. ON THE FOURTH ATTEMPT, THE CATHETER BECAME LODGED IN THE PT. AFTER THE PROCEDURE, THE PT CLAIMED PAIN, PRESENTED PNEUMOTHORAX AND WAS DIRECTED TO CHEST DRAIN. THE NEXT DAY, THE PT WAS DIRECTED TO THE HEMODYNAMIC SECTOR TO SURGICALLY REMOVE THE REMAINING PART OF THE CATHETER, AS THE CATHETER WAS FOUND BROKEN. IT IS UNK WHETHER THE CATHETER BROKE BEFORE, DURING OR AFTER INSERTION. DUE TO THE MANY ATTEMPTS AT INSERTION, THE PT EXPERIENCED BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INTRACATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 7277819

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other