BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN® SAFETY¿

    MDR report key: 5346876 · Received January 7, 2005

    Report

    Report Number
    2523676-2004-00093
    Event Type
    Other
    Date Received
    January 7, 2005
    Date of Event
    December 1, 2004
    Report Date
    January 4, 2005
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION. SEVERAL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE AND ADDITIONAL INFO ABOUT THE INCIDENT FROM THE USER FACILITY WITHOUT SUCCESS. WITHOUT THE ACTUAL DEVICE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(6) 2004 @ 18:55PM IV CATHETER WAS BEING REMOVED FROM LEFT ARM DUE TO INFILTRATION WHEN 1/2 OF CATHETER BROKE OFF DURING REMOVAL. NURSE REPORTED THAT HE COULD HEAR CATHETER "SNAP". PATIENT WAS A (B)(6) FEMALE THAT HAS SINCE BEEN DISCHARGED. X RAYS WERE TAKEN OF IV SITE, CHEST AND A CAT SCAN WAS ALSO DONE. CATHETER WAS NOT LOCATED ON ANY OF THE X-RAYS OR SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN® SAFETY¿ I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other