BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3952252 · Received July 3, 2014

    Report

    Report Number
    9610825-2014-00231
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN A FOLLOW UP WITH THE REPORTER, SHE STATED THAT "THE NURSE HAD BEEN CALLED DOWN TO CT SCAN TO START A 20 ANGIO ON HER PATIENT FOR POWER INJECTING OF CONTRAST. SHE HAD ONLY ONE ANGIO WITH HER AND AN IV START KIT. SHE ATTEMPTED ONE STICK, FAILED TO CANNULATE THE VEIN AND 'BECAUSE I SEE THE DOCTORS DOING IT ALL THE TIME, I USED THE SAME CATHETER FOR MY SECOND ATTEMPT.' AS SHE STUCK THE PATIENT, HE FLINCHED AND THE CATHETER GLANCED OFF HIS FOREARM AND INTO HER FINGER." THE REPORTER ALSO STATED THAT THE NURSE INVOLVED IN THE EVENT "WAS NOT PROPERLY ADVISED TO FOLLOW UP WITH EMPLOYEE HEALTH AND RECEIVED IMMEDIATE TREATMENT IN THE ED. NO SOURCE PATIENT TESTING WAS PERFORMED. WHEN SHE DID GO TO EMPLOYEE HEALTH A WEEK LATER, IT WAS TOO LATE TO OFFER HER THE PROPHYLAXIS. SHE WILL HAVE FOLLOW UP LABS AT 6 WEEKS, 3 MONTHS AND 1 YEAR. SHE WAS REMEDIATED BY NURSING EDUCATION THIS AFTERNOON AND RE-EDUCATED ON THE SINGLE PUNCTURE USE OF THE CATHETER GOING FORWARD." ALL AVAILABLE INFORMATION WAS FORWARDED TO THE ACTUAL MANUFACTURER, B. BRAUN (B)(4). THEIR REPORT STATES THAT THEY WERE NOT ABLE TO REVIEW THE BATCH HISTORY RECORD BECAUSE THE DEVICE HISTORY RECORD BATCH NUMBER DOES NOT EXIST IN OUR (B)(4) SYSTEM. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADVERSE TRENDS OF THIS NATURE FOR PRODUCT CODE 4251644-02. WITHOUT THE ACTUAL SAMPLE OR CORRECT LOT NUMBER, FURTHER EVALUATION WAS NOT POSSIBLE. NO SPECIFIC CONCLUSION CAN BE DRAWN. HOWEVER, THE IFU CLEARLY INDICATES FOR SINGLE USE ONLY. ADDITIONALLY, IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLE STICK INJURIES. CDC GUIDELINES AND/OR FACILITY PROTOCOLS SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. IF THE SAMPLE AND ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391026 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1