BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD YEL 24GA X .75IN

    MDR report key: 10978746 · Received December 9, 2020

    Report

    Report Number
    1710034-2020-00787
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 4, 2020
    Report Date
    January 16, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD YEL 24GA X .75IN NEEDLE WOULD NOT FULLY RETRACT. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 0080382. IT WAS REPORTED THAT NEEDLE DOES NOT FULLY RETRACT, LEAVING A 1/2 INCH OF THE NEEDLE EXPOSED. PER EMAIL: I AM A NUCLEAR MEDICINE TECHNOLOGIST IN A CARDIOLOGY OFFICE. WE START MANY IV'S FOR OUR TESTING AND HAVE BEEN USING BD PRODUCTS FOR MANY YEARS. RECENTLY WE HAVE HAD AN ISSUE WITH THE 24 GAUGE X 0.75" BD INSYTE AUTOGUARD CATHETERS NOT FULLY RETRACTING THE NEEDLE. THIS WILL NOT BE THE CASE WITH EACH ONE, BUT JUST HAPPEN RANDOMLY. WE HAVE HAD THIS HAPPEN 6 TIMES NOW. UPON PRESSING THE BUTTON TO RETRACT THE NEEDLE, A 1/2 INCH OF THE NEEDLE WILL REMAIN EXPOSED. AS YOU KNOW, THIS IS VERY HAZARDOUS AND PUTS US AT GREAT RISK OF PUNCTURING OURSELVES WITH A CONTAMINATED NEEDLE. THE REFERENCE NUMBER FOR THIS ITEM IS (B)(4) AND THE LOT NUMBER IS 0080382. PLEASE LET ME KNOW IF OTHERS HAVE REPORTED THIS ISSUE AND ADVISE HOW YOUR COMPANY WOULD LIKE TO HANDLE THIS DEFECT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE: 1536, FDA PATIENT PROBLEM CODE: 2199.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOGUARD YEL 24GA X .75IN NEEDLE WOULD NOT FULLY RETRACT. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 0080382 IT WAS REPORTED THAT NEEDLE DOES NOT FULLY RETRACT, LEAVING A 1/2 INCH OF THE NEEDLE EXPOSED. PER EMAIL: I AM A NUCLEAR MEDICINE TECHNOLOGIST IN A CARDIOLOGY OFFICE. WE START MANY IV'S FOR OUR TESTING AND HAVE BEEN USING BD PRODUCTS FOR MANY YEARS. RECENTLY WE HAVE HAD AN ISSUE WITH THE 24 GAUGE X 0.75" BD INSYTE AUTOGUARD CATHETERS NOT FULLY RETRACTING THE NEEDLE. THIS WILL NOT BE THE CASE WITH EACH ONE, BUT JUST HAPPEN RANDOMLY. WE HAVE HAD THIS HAPPEN 6 TIMES NOW. UPON PRESSING THE BUTTON TO RETRACT THE NEEDLE, A 1/2 INCH OF THE NEEDLE WILL REMAIN EXPOSED. AS YOU KNOW, THIS IS VERY HAZARDOUS AND PUTS US AT GREAT RISK OF PUNCTURING OURSELVES WITH A CONTAMINATED NEEDLE. THE REFERENCE NUMBER FOR THIS ITEM IS 381412 AND THE LOT NUMBER IS 0080382. PLEASE LET ME KNOW IF OTHERS HAVE REPORTED THIS ISSUE AND ADVISE HOW YOUR COMPANY WOULD LIKE TO HANDLE THIS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439414 INSYTE AUTOGUARD YEL 24GA X .75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381412 0080382 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1