BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD 20 GA X 1.16IN

    MDR report key: 21942184 · Received May 1, 2025

    Report

    Report Number
    MW5169691
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 25, 2025
    Manufacturer
    BECTON DICKINSON AND COMPANY (BD)
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAVE REPORTED OTHER ISSUES WITH THE SAME PRODUCT EARLIER THIS YEAR ((B)(6) 2025) AND WITH THE SAME PRODUCT, DIFFERENT LOT NUMBER IN (B)(6) 2024. TODAY WE HAD 3 DIFFERENT ISSUES WITH IV CATHETERS. UNFORTUNATELY, ONLY ONE PACKAGING WAS SAVED. LOT 5045781 EXP 2028-01-31. ISSUE 1. RN 1: NEEDLE WOULD NOT RETRACT AFTER SLIDING CATHETER OFF OF THE NEEDLE. RETRACTOR BUTTON PUSHED MULTIPLE TIMES. EVENTUALLY RETRACTED AFTER INSYTE HELD UPRIGHT AWAY FROM NURSE AND THE PATIENT. ISSUE 2. RN 2: HOLDING INSYTE AUTOGUARD ABOUT TO POKE PATIENT TO ACCESS THE VEIN, WHEN THE CATHETER SPONTANEOUSLY POPPED OFF OF THE NEEDLE. THE CATHETER WAS NOT BEING ADVANCED OFF OF THE NEEDLE BY THE RN. ISSUE 3. HT: AFTER ADVANCING THE INSYTE AUTOGUARD AND OBSERVING THE BLOOD RETURN, SHE STARTED TO RETRACT THE NEEDLE BUT FELT RESISTANCE. SOMETHING ABOUT THE CATHETER AT THIS POINT FELT WRONG. SHE THEN PULLED BACK ON BOTH THE NEEDLE AND THE CATHETER TO REMOVE THEM FROM THE PATIENT. ONCE REMOVED FROM THE PATIENT, SHE OBSERVED THAT THE CATHETER WAS SPLIT IN HALF. CATHETER INSPECTED BY HT AND OTHERS WHO NOTED THAT WHILE THE CATHETER WAS SPLIT, ALL OF THE PIECES WERE PRESENT. ACTION: LOGISTICS CALLED, INFORMED OF EXPERIENCES TODAY. CATHETERS OF THE SAME LOT, COLLECTED AND RETURNED TO LOGISTICS. REFERENCE REPORT: MW5169692, MW5169693.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207460 INSYTE AUTOGUARD 20 GA X 1.16IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON AND COMPANY (BD) 5045781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown