BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN® SAFETY

    MDR report key: 6777849 · Received August 9, 2017

    Report

    Report Number
    9610825-2017-00163
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 10, 2017
    Report Date
    January 4, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K982805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM BRAZIL TO BBM IN GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: BROKEN/ CAPILLARY

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4). WE RECEIVED ONLY ONE USED CAPILLARY AND ONE CANNULA OF A INTROCAN SAFETY PUR 18G, 1.3X45MM-SA WITHOUT PACKAGE. THE RETURNED CAPILLARY AND THE CANNULA WERE CHECKED VISUALLY. THE CAPILLARY WAS PENETRATED BY THE CANNULA APPROXIMATELY 13 MM AWAY FROM THE CAPILLARY TIP. THE AREA OF THE PUNCTURE SHOWS A V-SHAPED DAMAGE. WE ASSUME THAT THIS PUNCTURE WAS CAUSED BY THE INTROCAN CANNULA BY WITHDRAWING AND PUSHING FORWARD AGAIN. ACCORDING TO THIS DAMAGE WE ASSUME AN APPLICATION PROBLEM AND CONSIDER THE COMPLAINT AS NOT CONFIRMED. UNABLE TO REVIEW THE DEVICE HISTORY RECORDS AS THE PROVIDED BATCH NUMBER HAS NO VALUES IN OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560358 INTROCAN® SAFETY I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1