BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOCATH

    MDR report key: 89809 · Received May 7, 1997

    Report

    Report Number
    1710034-1997-00016
    Event Type
    Injury
    Date Received
    May 7, 1997
    Date of Event
    April 9, 1997
    Report Date
    April 9, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD-38-VISUAL EXAMINATION-SEM-SCANNING ELECTRONIC MICROSCOPE-37. RESULTS 208-200-EXAMINATION REVEALED THE CATHETER HAD BEEN CUT BY THE USER AFTER INSERTION AND FLEXED TO FAILURE. CONCLUSION-79-68 THE CATHETER WAS CUT BY THE USER AND PULLED OR FLEXED TO BREAKAGE. EXAMINATION OF THE CATHETER WITH SEM FOUND THAT THE CATHETER TUBING WAS IN VERY POOR CONDITION. THE ATTACHED SEM MICROPHOTOGRAPH SHOWS SEVERAL HOLE AND BREAKS IN THE CATHETER. THERE IS A LARGE HOLE IN THE CATHETER BETWEEN THE HUB AND THE TIP. THIS HOLE IS IN THE LOWER-LEFT OF THE FIRST ATTACHED MICROPHOTOGRAPH. THIS HOLE, SHOWN BETTER IN THE SECOND MICROPHOTOGRAPH, APPEARS TO HAVE BEEN CAUSED BY STRESS. THERE IS A HOLE NEAR THE TIP WHICH PROBABLY WAS MADE BY SOMETHING PUSHING OUT FROM INSIDE OF THE TUBING. A CLOSE UP OF THIS HOLE IS SHOWN IN THE THIRD MICROPHOTOGRAPH. THERE ARE SEVERAL OTHER SMALLER HOLES IS THE TUBING. ONE OF THESE HOLES IS SHOWN IN THE FOURTH MICROPHOTOGRAPH. THIS HOLE IS JUST BEHIND THE HOLE NEAR THE TIP. THE PRESENCE OF ALL OF THESE SMALLER HOLES IS VERY UNUSUAL AND INDICATES EITHER DEGRADATION OR ABUSE OF THE CATHETER TUBING. IT IS DIFFICULT OT RECONSTRUCT WHAT HAPPENED TO THIS CATHETER, BUT IS CLEARLY WAS SUBJECTED TO ROUGH TREATMENT.

    Description of Event or Problem · 1

    ANGIOCATH 24 GAUGE CATHETER WAS EITHER SHEARED OR BROKEN. THE CATHETER WAS PLACED IN THE LEFT HAND. THE NURSE SUPERVISOR SUGGESTED THE CATHETER MAY HAVE BEEN BENT AND CUT BY THE FORCE OF FREQUENT WRIST MOTION. A CUTDOWN PROCEDURE WAS PERFORMED AND THE CATHETER PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOCATH PERIPHERAL VENOUS ACCESS CATHETER FOZ BECTON DICKINSON VASCULAR ACCESS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention