BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BL

    MDR report key: 17986634 · Received October 23, 2023

    Report

    Report Number
    1710034-2023-01213
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED 107 INSYTE AUTOGUARD 22GA X 1.00IN. UNITS FROM LOT NUMBER 3223518. ADDITIONALLY, ONE PHOTO WAS PROVIDED. SIX OF THE UNITS WERE PROVIDED UNSEALED AND USED. OF THE 6 UNITS, 3 OF THEM DISPLAYED A V SHAPE CUT ON THE CATHETER TUBING THAT RESEMBLES A NEEDLE SPEAR THROUGH PATTERN. OF THE 101 SEALED UNITS, A SAMPLING OF 20 UNITS WERE VISUALLY INSPECTED FOR ANY NEEDLE SPEAR THROUGH. OF THE 20 UNITS THAT WERE VISUALLY INSPECTED, ONE OF THEM DISPLAYED A NEEDLE SPEAR THROUGH. THE REPORTED ISSUE WAS CONFIRMED. AS ONE OF THE SEALED UNITS WAS CONFIRMED FOR THE NEEDLE PIERCING THROUGH THE CATHETER WALL, WE DETERMINED THIS MOST LIKELY OCCURRED DURING THE MANUFACTURING PROCESS. DURING MANUFACTURING, WHILE THE ADAPTER IS LOADED ONTO THE GRIP ASSEMBLY, THE ADAPTER IS PLACED TO PRE-SEAT TOOLING. INCORRECT EQUIPMENT SETTINGS MAY CAUSE THE CATHETER TO GET DAMAGED OR THE NEEDLE TO SPEAR THROUGH THE CATHETER TUBING. A 100% VISION SYSTEM, CHALLENGE SAMPLE, AND VISUAL INSPECTIONS PER QUALITY CONTROL PLANS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD BL 22GA X 1.0IN INSERTION ATTEMPTS RESULTED IN NEEDLE PIERCING THROUGH CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IV CATHETERS WERE EITHER SPLIT OR BENT STRAIGHT OUT OF THE PACKAGING AND OR AFTER AN IV START DIDN'T WORK AND WE LOOKED AT THE CATHETER YOU COULD SEE THE SPLIT AT THE TIP OF THE CATHETERS. (B)(6) 2023. HOW MANY OCCURRENCES OF DEFECTIVE SET(S) AFFECTED? WE HAD A WHOLE WEEK OF UNUSUAL DIFFICULT IV STARTS AND THEN WE TOOK NOTE AND STARTED REALLY LOOKING AT THE CATHETERS MORE CLOSELY. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO ADVERSE EVENTS. WHAT WAS THE PATIENT OUTCOME? THERE WAS AN INCREASE OF IV INFILTRATIONS AT IV STARTS DURING THE TIMEFRAME OF HAVING THESE CATHETERS IN STOCK. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? NO WE USED THE 20G NEEDLES. WHAT PROCEDURE WAS BEING PERFORMED? CT'S AND MRI'S. WHAT MEDICATION WAS USED IN THE PROCEDURE? GADAVIST AND OMNIPAQUE 350. WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO. IS SAMPLE AVAILABLE FOR RETURN TO BD FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE SENDER¿S NAME AND ADDRESS FOR US TO CREATE THE FEDEX RETURN LABEL. ADDRESS:XXXX. IF SAMPLE IS NOT AVAILABLE, ARE YOU ABLE TO PROVIDE PHOTO(S) OF THE SAMPLE AND THE DEFECT? ATTACHED (B)(6)2023. 1. AS YOU STATED THE IV CATHETERS ARE EITHER SPLIT OR BENT STRAIGHT OUT OF THE PACKAGING. A. DO THE CATHETER TIPS APPEAR FRAYED OR SPLIT? YES. B. DID THE NEEDLE SPEAR THROUGH THE CATHETER WALL AND THAT IS WHY IT APPEARS SPLIT? YES , IT POKED THROUGH ON SOME OF THE CATHETERS. C. ARE THE NEEDLES BENT IN THE PACKAGE OR IS THE PACKAGE DAMAGED DUE TO THE BENT NEEDLE? NEITHER, THE PACKAGING SEEMED FINE AND THE CATHETERS/NEEDLES ARE NOT BENT. 2. 2. AFTER AN IV START DIDN¿T WORK, THE CATHETER WAS FOUND SPLIT AT THE TIP. A. DID THE NEEDLE SPEAR THOUGH THE CATHETER WALL UPON INSERTION? YES, AFTER ATTEMPTING TO ADVANCE THE CATHETER IT WAS EVIDENT THE NEEDLE HAD SPEARED THROUGH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856767 BD INSYTE AUTOGUARD BL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3223518 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown