BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) INSYTE

    MDR report key: 8519605 · Received April 16, 2019

    Report

    Report Number
    8041187-2019-00308
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903812340
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. SINCE NO SAMPLES OR PHOTOS DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE EXPERIENCED PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER DAMAGED, MATERIAL: 381234, BATCH; 5142297, QUANTITY: 1.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE EXPERIENCED PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER DAMAGED, MATERIAL: 381234, BATCH; 5142297, QUANTITY: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314456 20G X 1.16IN (1.1 X 30 MM) INSYTE INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 5142297 30382903812340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other