BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25028062 · Received April 29, 2026

    Report

    Report Number
    1710034-2026-00479
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINTS OF DAMAGED PACKAGING AND RETRACTED NEEDLES WERE CONFIRMED. THREE 18G INSYTE AUTOGUARD DEVICES WERE RECEIVED WITH OPEN UNIT PACKAGES FROM LOT #4162541. EACH NEEDLE WAS RECEIVED FULLY RETRACTED WITHIN THE SAFETY SHIELD. THE CAUSE OF THE PREMATURE NEEDLE RETRACTION COULD NOT BE IDENTIFIED FROM THE RETURNED SAMPLES. THE OBSERVED PREMATURE RETRACTION COULD BE RELATED TO THE DAMAGED PACKAGING; HOWEVER, A CONCLUSIVE ASSOCIATION COULD NOT BE IDENTIFIED. THE IV CATHETERS WERE POSITIONED WITHIN THE NEEDLE COVERS AND THE NEEDLE COVERS WERE RECEIVED OVER THE END OF EACH GRIP. A HOLE WAS VISIBLE AT EACH END OF EACH RETURNED BOTTOM WEB PACKAGING. THE BOTTOM WEB MATERIAL WAS WRINKLED AROUND EACH HOLE. THE DAMAGED PACKAGING LIKELY OCCURRED DURING THE PACKAGING PROCESS. THERE WERE NO OTHER SIMILAR COMPLAINTS FROM THE IMPLICATED LOT; THEREFORE, THE DAMAGE COULD BE ISOLATED TO THE FIVE UNIT PACKAGES THAT ARE FORMED AT THE SAME TIME. NO ADDITIONAL ACTION WAS TAKEN, AND SIMILAR COMPLAINTS WILL CONTINUE TO BE MONITORED TO DETERMINE THE NEED FOR ESCALATION AND ADDITIONAL ACTION. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THE BREACH IN THE BOTTOM WEB PACKAGING. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. COMPLAINTS RECEIVED ABOUT THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIMARY PACKAGING HAD HOLES AND THE NEEDLES HAD RETRACTED WITHIN THE UNIT PACKAGE. FIVE PACKAGES WERE OPENED WITH ALL TO HAVE HAD THE SAFETY PORTION ALREADY DEPLOYED AND SEPARATED FROM THE IV CATHETER. THE OUTER PACKING HAD SMALL HOLES ON BOTH ENDS OF THE CLEAR PLASTIC PART. 3 OF THE FIVE AFFECTED ITEMS WERE SAVED FOR INVESTIGATION AS NEEDED. I HAVE ADDED OUR CLINICAL CONTACTS, PAM AND ASHLEY, WHO CAN ASSIST WITH ANSWERING ADDITIONAL QUESTIONS AND SENDING IN PRODUCT AS NEEDED. PLEASE REPLY ALL TO THIS EMAIL SO EVERYONE STAYS INFORMED ON THE LATEST INFORMATION. I APPRECIATE THE TIMELY RESPONSE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586939 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4162541 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown