BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N IV CATHETER 24GA 0.56IN

    MDR report key: 11715821 · Received April 23, 2021

    Report

    Report Number
    8041187-2021-00341
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 25, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE INSYTE-N PRODUCT IS DESIGNED WITH A NOTCH ON THE CANNULA TIP AS A PRODUCT FEATURE FOR FLASHBACK VISUAL INDICATION. THEREFORE, THIS IS NOT A PRODUCT DEFECT. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE-N¿ IV CATHETERS 24GA 0.56IN EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381211; BATCH NO: 0022387, 9353071. CONSUMER CONCERNED ABOUT THE TIP OF PRODUCT. INSTEAD OF NEEDLE BEING COMPLETELY SOLID THERE IS A GROVE ABOUT 2MM TOWARDS THE TIP. THE CUSTOMER PURCHASED THE PRODUCT FROM THE DISTRIBUTOR.

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0022387. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-01-22. MEDICAL DEVICE LOT #: 9353071. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2019-12-19. 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 2 BD INSYTE-N¿ IV CATHETERS 24GA 0.56IN EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381211, BATCH NO: 0022387, 9353071. CONSUMER CONCERNED ABOUT THE TIP OF PRODUCT. INSTEAD OF NEEDLE BEING COMPLETELY SOLID THERE IS A GROVE ABOUT 2MM TOWARDS THE TIP. THE CUSTOMER PURCHASED THE PRODUCT FROM THE DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616244 BD INSYTE-N IV CATHETER 24GA 0.56IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9353071

    Patients

    Seq Age Sex Outcome Treatment
    1