BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD ANGIOCATH IV CATHETER

    MDR report key: 2062764 · Received April 8, 2011

    Report

    Report Number
    9610048-2011-00007
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    September 21, 2009
    Report Date
    November 19, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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 UNITED STATES. REFERENCE (B)(4). RESULTS: ONE UNIT WAS RECEIVED FOR EVAL. MICROSCOPIC INSPECTIONS REVEALED THAT A PORTION OF THE CATHETER TUBING WAS SECURELY ATTACHED TO THE METAL WEDGE WITHIN THE PLASTIC ADAPTER. THE REMAINING CATHETER TUBING WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY FILES REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 9014138. (B)(4). CONCLUSIONS: WE WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS INCIDENT WE COULD NOT IDENTIFY WHEN OR HOW THE DAMAGE TO THE UNIT OCCURRED.

    Description of Event or Problem · 1

    THE CATHETER SEPARATED FROM THE PLASTIC ADAPTER AFTER INSERTION, LEAVING THE CATHETER TUBING IN THE PT'S VEIN. THE TECHNICAL DIRECTOR WAS CALLED FOR EVAL, AN RX WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 9014138

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other