BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN® SAFETY

    MDR report key: 4884618 · Received July 1, 2015

    Report

    Report Number
    9610825-2015-00234
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 10, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. PICTURE DOCUMENTATION (INFORMATION FROM CUSTOMER) OF THE FAILED DEVICE WAS REVIEWED AND FOUND THAT THE CAPILLARY IS NOT SEEN AT THE CAPILLARY HUB. IT MAY BE EITHER DETACHED OR BROKEN-OFF CAPILLARY. BASED ON PICTURES, UNABLE TO VERIFY WHETHER ANY REMAINING PART OF THE CAPILLARY IN THE HUB. HOWEVER, NO SAMPLE WAS RETURNED FOR EVALUATION AND NO CONCLUSION COULD BE DRAWN FROM THE PHOTO. BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. HENCE WE ASSESS THIS COMPLAINT TO BE NOT JUDGABLE. REVIEWED DEVICE HISTORY RECORDS AND MACHINE PROCESS CARDS. NO DEFECTS OF DETACHED CANNULA/CAPILLARY WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): THE CANNULA OF THE PERIPHERAL CATHETER DETACHED FROM THE CANNON, REMAINING AT THE PATIENT JUGULAR VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427817 INTROCAN® SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG N/A 14G10G8244

    Patients

    Seq Age Sex Outcome Treatment
    1 Other