BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 20582560 · Received October 31, 2024

    Report

    Report Number
    1710034-2024-01247
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 9, 2024
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 Manufacturer Narrative · 0

    EVENT DATE UPDATED IN B TAB. INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 127 SEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC WINGED UNITS FROM LOT NUMBER 4222721 AND 46 SEALED UNITS FROM LOT NUMBER 4123611. A SAMPLING OF 20 UNITS FROM LOT NUMBER 4123611 WERE RANDOMLY SELECTED FOR TESTING OF THREADING DIFFICULTIES. ALL UNITS PAST INSPECTION AND NO DAMAGES TO THE THREADING OR ISSUES WHEN ADVANCING THE CATHETER WERE DISCOVERED, HOWEVER A SLOW RETRACTION WAS OBSERVED. A SAMPLING OF 20 UNITS FROM LOT NUMBER 4222721 WERE RANDOMLY SELECTED FOR FUNCTIONAL TESTING. THE 20 SEALED UNITS WERE TESTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING THE CATHETER, AND THEN ACTIVATING THE BUTTON. THIS FUNCTIONAL TEST REVEALED THAT THE RETRACTION TIME OF SOME OF THE NEEDLES EXCEEDED THE 1.5 SECOND SPECIFICATION. YOUR REPORTED ISSUE WAS CONFIRMED AS A SLOW RETRACTION. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO EXCESSIVE GEL IN THE SPACE BETWEEN THE FLASH CHAMBER AND THE GRIP. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE IVS WOULD NOT DEPLOY AND THE OTHER HAD A DEFECTIVE SAFETY MECHANISM. THEY HAVE SEEN SEVERAL OF THESE INCIDENTS WITH THE TWO LOTS NOTED. THE NURSE SUPERVISOR INFORMED ME THAT THE ED NURSES WERE HAVING TROUBLE WITH THESE 20GA. IV CATHETERS. WHEN THEY PUSH THE WHITE BUTTON ON THE CATHETER IT IS HAVING A SLOW DELAY ON RETRACTING. WHEN NORMALLY IT RETRACTS QUICKLY.

    Description of Event or Problem · 0

    DATE OF EVENT HAS BEEN UPDATED TO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960821 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222721 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown