BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2259126 · Received September 14, 2011

    Report

    Report Number
    9610825-2011-00130
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 14, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MANUFACTURER), AND B. BRAUN (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. BATCH RECORD REVIEW OF THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE DURING INPROCESS OR FINAL CONTROL INSPECTION. IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLESTICK INJURIES. HOWEVER, CDC GUIDELINES AND/OR FACILITY PROTOCOLS SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER FOR FURTHER EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: ON (B)(6) 2011, THE SAFETY DEVICE ON A BRAUN INTROCAN #22 GAUGE CATHETER DID NOT AUTOMATICALLY ACTIVATE AS DESIGNED WHEN THE NEEDLE WAS WITHDRAWN. THE NURSE WAS PUNCTURED WITH THE CONTAMINATED NEEDLE WHILE DISPOSING OF THE USED NEEDLE. ADDITIONAL INFORMATION RECEIVED INDICATES THE EMPLOYEE DID NOT REALIZE THE CLIP WAS NOT ACTIVATED. THE EMPLOYEE HAD ROUTINE FOLLOW UP, SOURCE PATIENT (B)(6); EMPLOYEE WILL HAVE ON GOING MONITORING FOR SIX MONTHS. NO SAMPLE AVAILABLE, HAD BEEN DISCARDED IN SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 1B02258303

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other