BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD

    MDR report key: 9130588 · Received September 27, 2019

    Report

    Report Number
    1710034-2019-01059
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    July 26, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD HAS BEEN FOUND EXPERIENCING EIGHT OCCURRENCES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE EXTENSION SET LEAKED WHERE IT CONNECTS TO THE CATHETER. PR 9 OF 9: FOR DATE OF EVENT (B)(6) 2019. PER EMAIL: CAN YOU PLEASE PROVIDE A BRIEF DESCRIPTION OF THE EVENT? TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED. WHERE DID THE LEAK OCCUR? AT THE CATHETER CONNECTION WHAT WAS THE SET MATED TO? BD INSYTE AUTOGUARAD 24 GA WHAT IS THE MODEL / LOT NUMBER FOR IV SET? SMARTSITE EXTENSION 20039E WHAT WAS THE INTENDED PROGRAMMING (RATE, VOLUME, DURATION, CONCENTRATION AND SIZE OF THE BAG) 125 ML/HR WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT (ANY PATIENT HARM OR MEDICAL INTERVENTION?): NO. WHAT IS THE BD REFERENCE # AND LOT # OF THE 24G INSYTE AUTOGUARD? REF 381412 LOT #S 9128619 AND 9122769.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9128619. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-08. MEDICAL DEVICE LOT #: 9122769. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-02. INITIAL REPORTER FACILITY: THE USER FACILITY ADDRESS IS NOT AVAILABLE, THE CORPORATE HEADQUARTERS INFORMATION WAS USED INSTEAD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD HAS BEEN FOUND EXPERIENCING EIGHT OCCURRENCES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE EXTENSION SET LEAKED WHERE IT CONNECTS TO THE CATHETER. PR 9 OF 9: FOR DATE OF EVENT (B)(6) 2019. PER EMAIL: CAN YOU PLEASE PROVIDE A BRIEF DESCRIPTION OF THE EVENT? TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED. WHERE DID THE LEAK OCCUR? AT THE CATHETER CONNECTION. WHAT WAS THE SET MATED TO? BD INSYTE AUTOGUARAD 24 GA. WHAT IS THE MODEL / LOT NUMBER FOR IV SET? SMARTSITE EXTENSION 20039E. WHAT WAS THE INTENDED PROGRAMMING (RATE, VOLUME, DURATION, CONCENTRATION AND SIZE OF THE BAG)? 125 ML/HR. WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT (ANY PATIENT HARM OR MEDICAL INTERVENTION?)? NO. WHAT IS THE BD REFERENCE # AND LOT # OF THE 24G INSYTE AUTOGUARD? REF #: 381412. LOT #S: 9128619 AND 9122769.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925866 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other