BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2900190 · Received November 19, 2012

    Report

    Report Number
    9610825-2012-00232
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 16, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM IN (B)(4) FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY IN (B)(6): A PT ON (B)(6), HAD A 20 G INTROCAN PUR INSERTED, NO ISSUES. THE PT LEFT THE WARD FOR A CIGARETTE AND RETURNED SOMETIME LATER HOLDING THE HUB OF THE CANNULA, ALONG WITH THE NEEDLEFREE ATTACHED AND HANDED IT TO THE NURSE. A DR DISCUSSED THE OPTIONS FOR REMOVAL BUT THE PT INSISTED THAT IT BE REMOVED SURGICALLY. ANOTHER DR WITNESSED THE PT SCRATCHING HER ARM AND PUSHING DOWN ON IT MASSAGING THE CATHETER FURTHER INTO THE VEIN. IT HAS BEEN DOCUMENTED IN HER NOTES, THAT THE MEDICAL STAFF BELIEVE THIS TO BE DONE ON PURPOSE BY THE PT AND THAT SHE MAY HAVE OTHER UNDERLYING ISSUES. THE DR SAID THE PIECE OF CATHETER LEFT IN THE HUB IS TOO CLEAN CUT AND THAT HE IS CONVINCED THE PT DID IT HERSELF. THE PT WAS DUE TO GO TO THEATRE THIS AFTERNOON FOR THE CATHETER TO BE REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other