BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC GRN 18GA X 1.16IN

    MDR report key: 18637090 · Received February 3, 2024

    Report

    Report Number
    1710034-2024-00065
    Event Type
    Malfunction
    Date Received
    February 3, 2024
    Date of Event
    December 5, 2023
    Report Date
    April 12, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: LOT NUMBER CORRECTED SINCE INITIAL. EXPIRATION, MANUFACTURE DATE, AND UDI NUMBER ALL UPDATED TO REFLECT THE CORRECTION. INVESTIGATION RESULTS: RECEIVED TWO PHOTOS OF AN 18GA X 1.16IN. INSYTE AUTOGUARD BC UNIT. THE LOT#: 2230701 PROVIDED IN THE ENTRY DESCRIPTION IS NOT A VALID LOT NUMBER FOR THE MATERIAL#: 382544. FROM THE PROVIDED PHOTOS, THE LOT NUMBER IS 3198978. THE PHOTOS ONLY SHOW THE LABELING OF THE PACKAGE OF THE DEVICE, NO EVIDENCE OF THE UNIT OR ANY DEFECTS OF THE UNIT ARE DISPLAYED FROM THE PROVIDED PHOTOS. THE COMPLAINT COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. THE DHR FOR LOT 3198978 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. INVESTIGATION CONCLUSION(S): THE COMPLAINT OF ¿NEEDLE RETRACTION FAILURE¿ WAS NOT CONFIRMED. PROBABLE ROOT CAUSE(S): A ROOT CAUSE CANNOT BE DETERMINED WITHOUT A CONFIRMED DEFECT.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. E4. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 19/01/2024. MEDWATCH REPORT IS 3600840000-2024-8008 H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC GRN 18GA X 1.16IN NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED VIA MEDWATCH: "IV INSERTION, ANGIOCATH INSERTED, BUTTON FOR RETRACTING THE NEEDLE WOULD NOT WORK. THE NEEDLE WOULD NOT RETRACT. NO KNOWN HARM TO PATIENT. IV NOT SAVED, BUT PACKAGING WAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621180 BD INSYTE AUTOG BC GRN 18GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3198978 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown