BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18279889 · Received December 6, 2023

    Report

    Report Number
    1710034-2023-01408
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 12, 2023
    Report Date
    March 5, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814442
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381444 AND LOT NUMBER 3181569 AND 3178603. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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. A SECOND LOT NUMBER WAS REPORTED FOR MATERIAL # 381444 IN THIS COMPLAINT: LOT # 3181569 MNF 8 JUL 2023 EXP 30 JUN 2026.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLES BREAK DURING THE RETRACTION PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY TEAM IS REPORTING THAT OUR LATEST BATCH OF ANGIOCATHS SEEM TO BE MALFUNCTIONING, PARTICULARLY WHEN IT COMES TO RETRACTING THE NEEDLE AFTER PLACEMENT OF THE CANNULA. NEEDLES HAVE SNAPPED OFF AT THE HUB AS WELL. THIS OBVIOUSLY POSES A SERIOUS RISK OF NEEDLE STICK AND BODY FLUID EXPOSURE. THIS HAS OCCURRED SEVERAL TIMES. THE CUSTOMER IS NOT SURE EXACTLY HOW MANY TIMES THIS HAS OCCURRED BUT IT STARTED WITH THEIR NEWEST INVENTORY OF INSYTE PIVS. DESCRIBE PATIENT/HCP/USER IMPACT: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730630 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3178603 00382903814442

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown