BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21483297 · Received February 27, 2025

    Report

    Report Number
    1710034-2025-00331
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. ADDITIONAL LOT NUMBERS WERE PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 381412. LOT # 4155270. MNF DATE 2024-06-04. EXP DATE 2027-05-31. LOT # 4162507. MNF DATE 2024-06-12. EXP DATE 2027-05-31.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORT THAT THAT THE NEEDLE WOULD NOT RETRACT COULD NOT BE CONFIRMED FROM THE TWO 24G INSYTE AUTOGUARD DEVICES THAT WERE PROVIDED FOR INVESTIGATION FROM LOTS 4155270 AND 4162507. THE NEEDLES WERE RECEIVED FULLY RETRACTED WITHIN THE SAFETY SHIELD. AFTER RESETTING THE SAFETY MECHANISM, A FUNCTIONAL TEST SHOWED THAT THE NEEDLES WOULD FULLY RETRACT WHEN THE SAFETY MECHANISM WAS ACTIVATED. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. 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 BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR INFUSION DEPARTMENT RECENTLY MADE SUPPLY CHAIN AWARE OF RECURRING ISSUES USING THE #381412 - INSYTE AUTOGUARD IV START NEEDLES. THERE IS A TOTAL OF THREE LOTS AFFECTED THUS FAR. THE NEEDLES WOULD NOT RETRACT. CUSTOMER RESPONSE ON (B)(6)2025. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 01-31-2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM, BUT IV HAD TO BE RESTARTED

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286304 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4242433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown