BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC BLU 22GA X 1.0IN

    MDR report key: 19131461 · Received April 18, 2024

    Report

    Report Number
    1710034-2024-00340
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 22, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DATE OF EVENT PROVIDED BY CUSTOMER. UPDATED. INVESTIGATION RESULTS: THE COMPLAINT OF EXCESS GEL WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. THE PROVIDED PHOTOGRAPHS AND RETURNED SAMPLES EXHIBITED EXCESS GEL ON THE SEALED 22G INSYTE AUTOGUARD UNITS. ALTHOUGH NOT CONFIRMED WITH THE REPRESENTATIVE SAMPLES, THE REPORTED NEEDLE RETRACTION ISSUES MAY HAVE BEEN A CASCADING ISSUE DUE TO EXCESS GEL. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE REPORTED PRODUCTION BATCHES. INVESTIGATION CONCLUSION(S): THE COMPLAINT OF ¿NEEDLE RETRACTION FAILURE¿ WAS NOT CONFIRMED. PROBABLE ROOT CAUSE CONCLUSION(S): A ROOT CAUSE CANNOT BE DETERMINED WITHOUT A CONFIRMED DEFECT; HOWEVER, EXCESS GEL MAY HAVE BEEN A POTENTIAL CONTRIBUTING FACTOR OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION FROM CUSTOMER: THIS EVENT WAS NOTED ON 3/22/24.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC BLU 22GA X 1.0IN NEEDLE RETRACTION FAILED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE ITEM IS #382523, LOT #3192172 22G INSYTE AUTO GUARD WITH BLOOD CONTROL CATHETERS. I HAVE STUMBLED UPON PROBABLY 45 OUT OF THE 50 IN THE BOX THAT ARE LEAKING SOME TYPE OF GREASY SUBSTANCE NEAR THE SPRING INSIDE THE NEEDLE RETRACTOR. UPON OPENING THEM, THIS SUBSTANCE GETS ALL OVER YOUR HANDS/GLOVES. I FEEL THIS IS A PRETTY SUBSTANTIAL PATIENT SAFETY AND INFECTION CONTROL PROBLEM. SOME OF THE CATHETERS ARE LEAKING SO MUCH OF THIS SUBSTANCE THAT YOU CAN SEE THE GREASE MARKS ON THE OUTSIDE OF THE PACKAGE. ALSO, NOT SURE IF IT'S RELATED TO THIS LEAKING SUBSTANCE, BUT THIS ALSO JAMS UP THE BUTTON TO RETRACT THE NEEDLE THEREFORE THE NEEDLE HAS A HARD TIME RETRACTING INTO THE DEVICE POSING ANOTHER SAFETY/INFECTION RISK OF HAVING AN EXPOSED/NONRETRACTABLE USED NEEDLE. I HAVE SEVERAL PICTURES OF SOME OF THEM WE OPENED FOR DEMONSTRATION PURPOSES AS WELL AS A VIDEO OF THE JAMMED NEEDLE RETRACTOR BUTTON IF YOU WOULD LIKE ME TO SEND THOSE OVER AS WELL. I HAVE ABOUT 8 BOXES OF THESE SAME LOT # CATHETERS THAT I DON'T FEEL COMFORTABLE USING ON PATIENTS DUE TO THESE ISSUES, SO I AM NOT SURE WHAT TO DO ABOUT THIS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE ITEM IS #382523, LOT #3192172 22G INSYTE AUTO GUARD WITH BLOOD CONTROL CATHETERS. I HAVE STUMBLED UPON PROBABLY 45 OUT OF THE 50 IN THE BOX THAT ARE LEAKING SOME TYPE OF GREASY SUBSTANCE NEAR THE SPRING INSIDE THE NEEDLE RETRACTOR. UPON OPENING THEM, THIS SUBSTANCE GETS ALL OVER YOUR HANDS/GLOVES. I FEEL THIS IS A PRETTY SUBSTANTIAL PATIENT SAFETY AND INFECTION CONTROL PROBLEM. SOME OF THE CATHETERS ARE LEAKING SO MUCH OF THIS SUBSTANCE THAT YOU CAN SEE THE GREASE MARKS ON THE OUTSIDE OF THE PACKAGE. ALSO, NOT SURE IF IT'S RELATED TO THIS LEAKING SUBSTANCE, BUT THIS ALSO JAMS UP THE BUTTON TO RETRACT THE NEEDLE THEREFORE THE NEEDLE HAS A HARD TIME RETRACTING INTO THE DEVICE POSING ANOTHER SAFETY/INFECTION RISK OF HAVING AN EXPOSED/NONRETRACTABLE USED NEEDLE. I HAVE SEVERAL PICTURES OF SOME OF THEM WE OPENED FOR DEMONSTRATION PURPOSES AS WELL AS A VIDEO OF THE JAMMED NEEDLE RETRACTOR BUTTON IF YOU WOULD LIKE ME TO SEND THOSE OVER AS WELL. I HAVE ABOUT 8 BOXES OF THESE SAME LOT # CATHETERS THAT I DON'T FEEL COMFORTABLE USING ON PATIENTS DUE TO THESE ISSUES, SO I AM NOT SURE WHAT TO DO ABOUT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512228 BD INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192172 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown