BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE IV CATHETER

    MDR report key: 2062763 · Received April 8, 2011

    Report

    Report Number
    9610048-2011-00006
    Event Type
    Other
    Date Received
    April 8, 2011
    Report Date
    January 8, 2010
    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 US. (B)(4) - RESULTS: THE SAMPLE WAS RECEIVED FOR EVAL. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND CONFIRMED THAT THE NEEDLE WAS SEPARATED FROM THE HUB. A REVIEW OF THE LOT HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 8121990. CONCLUSIONS: THE ENGINEER CONCLUDES THAT THE INCIDENT OCCURRED DUE TO INSUFFICIENT ADHESIVE APPLIED TO THE HUB DURING THE ASSEMBLY PROCESS. THE OPERATORS AND INSPECTORS OF QUALITY CONTROL TESTING WERE RETRAINED TO THE EXISTING STATISTICAL SAMPLING PLAN REQUIREMENTS FOR THE MFG OF INSYTE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    AFTER THE CATHETER WAS INSERTED AND THE NEEDLE WAS BEING REMOVED, THE NEEDLE SEPARATED FROM THE HUB. THE DEVICE WAS REMOVED AND A NEW UNIT WAS INSERTED WITHOUT COMPLICATIONS. NO SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 8121990

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other