BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 20362775 · Received October 3, 2024

    Report

    Report Number
    1710034-2024-01111
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 17, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    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

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE Q-SYTE AND ONE CATHETER ASSEMBLY OF A 22 G X 1.00 IN INSYTE AUTOGUARD DEVICE. THE CATHETER WAS FROM LOT NUMBER 4162539 AND THE Q-SYTE CONNECTOR FROM LOT NUMBER 3312313. INVESTIGATION WAS CONDUCTED ON BOTH THE CATHETER AND THE Q-SYTE CONNECTOR. NO DEFECT WAS OBSERVED ON THE Q-SYTE THOUGH THE CATHETER HAS SOME DAMAGE TO THE THREADS ON THE BLUE CATHETER ADAPTER. THE DAMAGE OBSERVED IS LIKELY TO AFFECT THE THREADED CONNECTION WHEN ATTACHING THE CONNECTOR TO THE CATHETER ADAPTER. YOUR REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED. DURING MANUFACTURING, DAMAGE TO THE OUTSIDE OF THE ADAPTER MAY OCCUR IN ZONES THAT AN ADAPTER LUER ENCOUNTERS EQUIPMENT. MISALIGNMENTS OF THE ADAPTER RELATIVE TO THE EQUIPMENT MAY ALSO CAUSE THIS DAMAGE. ALIGNMENTS ARE PERFORMED WHEN THEY ARE DETERMINED TO BE NECESSARY DURING SET UP OR PRODUCTION. INSPECTION FOR DAMAGE TO THE ADAPTER IS PERFORMED BY OPERATORS PER THE SAMPLING PLAN. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: DATE OF OCCURRENCE: ON (B)(6) 2024. PLACEMENT OF A 22G CATHETER IN A PATIENT UNDERGOING CATARACT SURGERY RIGHT EYE. UNABLE TO SCREW THE ANTI-REFLUX VALVE ONTO THE CATHETER. PROBLEM ALREADY OBSERVED WITH THE SAME DEVICE. CHANGE OF CATHETER, MATERIAL KEPT SUPPLIER INFORMED HAS THERE BEEN AN IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE IN TREATMENT NECESSARY)? CHANGE OF CATHETER BUT NO OTHER IMPACT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040799 BD INSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4162539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown