BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2481759 · Received February 24, 2012

    Report

    Report Number
    9610825-2012-00014
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 24, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4). BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). ALL AVAILABLE INFO WAS FORWARDED TO THE ACTUAL MFR FOR FURTHER EVALUATION. THEY CONDUCTED A BATCH REVIEW AND NO ABNORMALITIES I THE MFR OF THE PRODUCT WERE NOTED. THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS DISCARDED AT THE FACILITY AND WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. WHILE NO SPECIFIC CONCLUSIONS CAN BE DRAWN, THE FACILITY REPORT DID INDICATE THAT THE NURSE SET THE DEVICE ON THE BED AFTER IV INSERTION AND THE LAB TECHNICIAN RECEIVED THE NEEDLE STICK WHEN REACHING INTO THE BED TO RETRIEVE TUBES OF BLOOD. FOLLOWING CDC GUIDELINES AND/OR FACILITY PROTOCOLS, SHARPS SHOULD ALWAYS BE IMMEDIATELY DISPOSED INTO AN APPROPRIATE SHARPS CONTAINER.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CLIP DID NOT FULLY DEPLOY RESULTING IN NEEDLE STICK. THE NURSE SET THE NEEDLE IN THE BED AND DREW BLOOD FROM THE IV CATHETER. THE LAB TECH REACHED INTO THE BED AND PICKED UP THE TUBES OF BLOOD. SHE WAS STUCK BY THE NEEDLE. THE NURSE REPORTED THE SHIELD DID NOT FULLY DEPLOY. THE PRODUCT WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 1I27258315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other