BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCANS SAFETY

    MDR report key: 3159795 · Received April 25, 2013

    Report

    Report Number
    2523676-2013-00109
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 28, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS CATHETER SHEARED AND STAYED IN PATIENT'S HAND, NEEDING TO BE REMOVED SURGICALLY WITH SMALL INCISION AND STITCHES TO CLOSE. CUSTOMER WILL NOT RELINQUISH SAMPLE, BUT SALES REP DID SEE SAMPLE 1/4 TO 1/8 INCH OF CATHETER REMAINS ATTACHED TO HUB. CUSTOMER WAS UNABLE TO DETAIL EXACTLY HOW LONG CATHETER DWELLED IN PATIENT BUT ISSUE OCCURRED UPON REMOVAL OF IV CATHETER FROM THE BACK OF THE PATIENT'S HAND. PATIENT HAS ALERTED THE FACILITY HE HAS PAIN, DECREASED ABILITY TO MOVE HAND AND INABILITY TO MAKE FIST WITH HAND. LOT NUMBERS ON HAND RECEIVED FROM HOSPITAL VIA E-MAIL ON (B)(6) 2013: 2K01258370 - MFG. DATE 10/2012, EXP. DATE 10/01/2017; 2L29258318 - MFG DATE: 11/2012, EXP. DATE 11/01/2017; 2K16258318 - MFG DATE: 10/2012, EXP. DATE 10/01/2017; 2K16258315 - MFG DATE: 10/2012, EXP. DATE 10/01/2017; 2M02258316 - MFG DATE: 12/2012, EXP. DATE 12/01/2017. REFERENCE MFR # 9610825-2013-00109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181244 INTROCANS SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 2K01258370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R