BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD YEL 24GA X .75IN

    MDR report key: 10988816 · Received December 10, 2020

    Report

    Report Number
    1710034-2020-00791
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 13, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL?: YES. D10. RETURNED TO MANUFACTURER ON: (B)(6) 2020. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED THREE USED AND PARTIALLY RETRACTED UNITS FROM REF (B)(4), LOT 0080382. UPON INSPECTION OF THE RECEIVED UNITS, ALL THREE UNITS HAD DAMAGE TO THE GRIP. THE GRIP WAS FOUND TO BE SLIGHTLY WARPED INWARD ACTING AS A STOP WHEN THE UNITS WERE RETRACTED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING EQUIPMENT RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A POSSIBLE MISALIGNMENT OF THE PLUG PROBE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD YEL 24GA X .75IN NEEDLE WOULD NOT FULLY RETRACT. 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 INITIAL 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.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOGUARD YEL 24GA X .75IN NEEDLE WOULD NOT FULLY RETRACT. 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 INITIAL 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454269 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