BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 5914094 · Received August 30, 2016

    Report

    Report Number
    9610825-2016-00583
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    July 24, 2016
    Report Date
    August 15, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K021094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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 MEDICAL INTERNAL REPORT NUMBER (B)(4). MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN A SAMPLE AND LOT NUMBER. NO SAMPLE WAS RETURNED FOR EVALUATION ; BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE AND NO CONCLUSION COULD BE DRAWN. HENCE, THE COMPLAINT IS ASSESSED TO BE NOT "JUDGABLE". IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED. DEVICE HISTORY RECORD (DHR): REVIEW OF THE DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED BECAUSE THE LOT NUMBER WAS REPORTED AS UNKNOWN.

    Description of Event or Problem · 0

    PER MEDWATCH NUMBER 5063791. EVENT DESCRIPTION: AN INTRAVENOUS CATHETER BROKE OFF AT THE HUB UPON REMOVAL FROM A PATIENT'S LEFT ARM. THE CATHETER PIECE WAS LEFT IN THE PATIENT'S ARM. STUDIES HAD TO BE COMPLETED TO VERIFY PLACEMENT OF THE IV CATHETER AND THEN SUBSEQUENT SURGICAL REMOVAL OF THE PIECE. IV INTROCAN 22 GUAGE CATHETER PLACED. DEVICE WILL NOT BE AVAILABLE FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566996 INTROCAN SAFETY® I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1