BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD ANGIOCATH IV CATHETER

    MDR report key: 2062805 · Received April 8, 2011

    Report

    Report Number
    9610048-2011-00008
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2009
    Report Date
    March 16, 2009
    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: ONE USED UNIT WAS RECEIVED FOR EVAL. OUR QUALITY ENGINEER MICROSCOPICALLY INSPECTED THE RETURNED UNIT AND CONFIRMED THAT A SMALL PORTION OF CATHETER TUBING REMAINED ATTACHED TO THE PLASTIC ADAPTER AND ALSO OBSERVED THAT THE END OF THE CATHETER DISPLAYED CRUSHED EDGES, INDICATORS OF A CUT CATHETER. CONCLUSIONS: THE ENGINEER CONCLUDES THAT THE DAMAGE IS MOST LIKELY OCCURRED AS THE RESULT OF THE CATHETER TUBING COMING INTO CONTACT WITH A SHARP OBJECT OR INSTRUMENT. THE USER IS ADVISED TO NEVER USE SCISSORS AT OR NEAR THE INSERTION SITE. (B)(4).

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED INTO THE LEFT FOREARM ON (B)(6) 2009. DURING THE DRESSING CHANGE ON (B)(6) 2011, IT WAS OBSERVED THAT THE CATHETER HAD BROKEN AWAY FROM THE PLASTIC ADAPTER AND THE CATHETER TUBING REMAINED IN THE PT'S VEIN. THE DR WAS NOTIFIED AND AN X-RAY WAS PERFORMED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other