BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 18298215 · Received December 9, 2023

    Report

    Report Number
    1710034-2023-01434
    Event Type
    Malfunction
    Date Received
    December 9, 2023
    Date of Event
    November 13, 2023
    Report Date
    January 9, 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
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: 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 (B)(4) AND LOT NUMBER 3251068. 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. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    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

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE PIERCED THE CATHETER RESULTING IN BLOWN VEINS, AND AIR LEAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE PUNCTURED CATHETER (B)(6) 2023 CUSTOMER RESPONSE: 1. PLEASE DESCRIBE THE SPECIFIC ISSUE IN DETAIL? I HAVE HAD SEVERAL OF THE 20 G BD INSYTE NEEDLES POKE THROUGH THE CATHETER WHILE INSERTING AN IV 2. WHILE USING OR BEFORE USE? WHILE USING 3. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? PATIENTS WERE OKAY; JUST ENDED UP WITH BLOWN VEINS &/OR REMOVAL OF GOOD IVS BECAUSE OF A HOLE IN THE CATHETER & AIR LEAKS, SO PATIENTS HAD TO BE STUCK AGAIN 100% OF THE TIME THE PRODUCT MALFUNCTIONED. 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE PIERCED THE CATHETER RESULTING IN BLOWN VEINS, AND AIR LEAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE PUNCTURED CATHETER (B)(6) 2023 CUSTOMER RESPONSE: 1. PLEASE DESCRIBE THE SPECIFIC ISSUE IN DETAIL? I HAVE HAD SEVERAL OF THE 20 G BD INSYTE NEEDLES POKE THROUGH THE CATHETER WHILE INSERTING AN IV 2. WHILE USING OR BEFORE USE? WHILE USING. 3. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? PATIENTS WERE OKAY; JUST ENDED UP WITH BLOWN VEINS &/OR REMOVAL OF GOOD IVS BECAUSE OF A HOLE IN THE CATHETER & AIR LEAKS, SO PATIENTS HAD TO BE STUCK AGAIN 100% OF THE TIME THE PRODUCT MALFUNCTIONED. 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327910 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251068 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown