BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3360437 · Received September 17, 2013

    Report

    Report Number
    2523676-2013-00272
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 7, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): WHEN THE CUSTOMER WOULD LIKE TO DRAPE, THE NURSE WAS STUCK ACCIDENTALLY BY THE NEEDLE. THEY FOUND THAT THE CLIP WAS NOT COVERING THE NEEDLE. THE PRODUCT IS INFECTED BY (B)(6). THE CUSTOMER REPORTED SIX POSSIBLE BATCHES: LOT #2K10258371, EXP DATE: 10/01/2017, MANUFACTURING DATE: 10/01/2012, AGE OF DEVICE: 1 YEAR. LOT #2L08258371, EXP DATE: 11/01/2017, MANUFACTURING DATE: 11/01/2012, AGE OF DEVICE: 1 YEAR. LOT #3A05258391, EXP DATE:01/01/2018, MANUFACTURING DATE: 01/01/2013, AGE OF DEVICE: 8 MONTHS. LOT #3B01258372, EXP DATE: 02/01/2018, MANUFACTURING DATE: 02/01/2013, AGE OF DEVICE: 7 MONTHS. LOT #3C03258392, EXP DATE: 03/01/2018, MANUFACTURING DATE: 03/01/2013, AGE OF DEVICE: 6 MONTHS. REF MFR REPORT 9610825-2013-00272.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468276 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 1K12258370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK