BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN

    MDR report key: 15273297 · Received August 23, 2022

    Report

    Report Number
    8041187-2022-00484
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    July 27, 2022
    Report Date
    August 24, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 10-AUG-2022 H6: INVESTIGATION SUMMARY THREE SAMPLES WITH OPEN PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. ONE SAMPLE WAS RECEIVED FROM LOT 1111450 AND TWO SAMPLES WERE RECEIVED FROM LOT 1298048. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR CATHETER DAMAGE. NO CATHETER DAMAGE WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE BEFORE USE ON SIX OCCASIONS THE BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN CATHETER WAS TORN. THIS OCCURRED SIX TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHETER TUBE IS TORN."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE BEFORE USE ON SIX OCCASIONS THE BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN CATHETER WAS TORN. THIS OCCURRED SIX TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHETER TUBE IS TORN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593795 BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1111450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown