BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 19766619 · Received July 17, 2024

    Report

    Report Number
    1710034-2024-00734
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 29, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381434 AND LOT NUMBER 3251084. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    MATERIAL # 381434. BATCH # 3251084. IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD PNK 20GA X 1.16IN HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: A FEW WEEKS AGO, WE HAD AN AUTOGUARD WHERE THE NEEDLE DIDN¿T RETRACT. THEY DID NOT KEEP THE ITEM, AS WE HAVE ASKED THEM TO DO MANY TIMES WHEN THIS HAPPENS, SO I AM NOT SURE WHAT CAN BE DONE, BUT WANTED TO GET YOUR OPINION AND SEE IF THERE HAS BEEN ANY ISSUES ELSEWHERE? THIS WAS FOR REF# (B)(4), WE BELIEVE THE LOT # WAS 3251084. ADDITIONAL INFORMATION PROVIDED: "HI. AFTER I STARTED THE IV, I PUSHED THE BUTTON TO RETRACT THE NEEDLE AND THE NEEDLE WOULD NOT RETRACT. IT FELT LIKE THE BUTTON WAS STUCK WHEN I PUSHED IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142831 BD INSYTE AUTOGUARD PNK 20GA X 1.16IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251084 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown