BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9444280 · Received December 10, 2019

    Report

    Report Number
    1710034-2019-01312
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 20, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    MATERIAL NO.: 381444 BATCH NO.: 9190471. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE BROKE OFF IN THE PATIENT'S ARM DURING INJECTION. THE NURSE WAS ABLE TO RETRIEVE THE NEEDLE THERE WAS NO HARM TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NEED TO REPORT A PRODUCT FAILURE ON ONE OF YOUR PRODUCT A INSYTE AUTOGUARD NEEDLE THE NEEDLE BROKE OFF IN THE PATIENTS ARM THE NURSE WAS ABLE TO RETRIEVE THE NEEDLE THERE WAS NO HARM TO THE PATIENT THE CATALOG NUMBER OF THE PRODUCT IS REF 381444 THE LOT NUMBER IS 9190471 I DO HAVE THE DEFECTED PRODUCT PLEASE ADVISE

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 381444, BATCH NO.: 9190471. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE BROKE OFF IN THE PATIENT'S ARM DURING INJECTION. THE NURSE WAS ABLE TO RETRIEVE THE NEEDLE THERE WAS NO HARM TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NEED TO REPORT A PRODUCT FAILURE ON ONE OF YOUR PRODUCT A INSYTE AUTOGUARD NEEDLE THE NEEDLE BROKE OFF IN THE PATIENTS ARM THE NURSE WAS ABLE TO RETRIEVE THE NEEDLE THERE WAS NO HARM TO THE PATIENT THE CATALOG NUMBER OF THE PRODUCT IS REF 381444 THE LOT NUMBER IS 9190471 I DO HAVE THE DEFECTED PRODUCT PLEASE ADVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243484 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381444 9190471 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other