BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 19751967 · Received July 16, 2024

    Report

    Report Number
    1710034-2024-00723
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    November 22, 2023
    Report Date
    July 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THIS MDR IS THE RESULT OF AN INVESTIGATION FINDING: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED 3 UNSEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC UNITS FROM LOT: 3251082. TWO OF THE UNITS DISPLAYED A V-SHAPED CUT IN THE CATHETER TUBING WHICH IS CONSISTENT WITH A NEEDLE PUNCTURING THE CATHETER TUBING. THE THIRD DEVICE WAS RETURNED WITH THE NEEDLE STILL PUNCTURING THE CATHETER TUBING. IN ALL THREE CASES THE LOCATION OF THE PUNCTURE IS NEAR THE TIP OF THE CATHETER TUBING AND LIKELY RESULTED IN AN INABILITY TO INSERT THE CATHETER TUBING AND A GENERAL FEELING OF DULLNESS IN THE NEEDLE. NEEDLE THROUGH CATHETER EVENTS CAN OCCUR AS A RESULT OF MANUFACTURING OR USE OF THE PRODUCT. MANUFACTURING GENERATED OCCURRENCES OF THIS NON-CONFORMANCE ARE MITIGATED BY A COMBINATION OF AUTOMATED VISUAL INSPECTION SYSTEMS AND COMPLETE PRODUCT INSPECTIONS BY TRAINED QUALITY PROFESSIONALS. BASED ON THE LOCATION AND APPEARANCE OF THE PUNCTURE OUR ENGINEERS WERE NOT ABLE TO ASSOCIATE THE ROOT CAUSE FOR THIS EVENT WITH THE MANUFACTURING PROCESS. IF A NEEDLE PUNCTURES THE CATHETER TUBING DURING MANUFACTURE, THE RESULTING PRODUCT WILL BE INOPERABLE. 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 AND COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC PNK 20GA X 1.0IN NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS MULTIPLE ISSUES WITH CATH, DIFFICULTY THREADING THE CATH ON AT LEAST 40-50 PLACEMENTS, THEY HAVE SEEN AN ISSUE EVERY DAY OVER THE PAST TWO WEEKS. SOME PATIENTS HAVE ALSO STATED THE NEEDLE IS DULL ON THIS LOT. BUT CLINICIANS HAVE BEEN ABLE TO GET NEEDLE IN AND THEN HAVING DIFFICULTY THREADING WHICH HAS CAUSED BLOWED VIENS. 10 JUL 2024 INVESTIGATION FINDING: NEEDLE THROUGH CATHETER LEAD TO THREADING DIFFICULTIES AND A PERCEPTION OF A DULL NEEDLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2518359 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251082 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown