BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING PNK 20GA X1.16IN

    MDR report key: 21753387 · Received April 2, 2025

    Report

    Report Number
    1710034-2025-00508
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 1, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826346
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382634 AND LOT NUMBER 4242432. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, 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 AUTOG BC WING PNK 20GA X1.16IN NEEDLE RETRACTION FAILED IT WAS REPORTED BY CUSTOMER THAT THERE WAS ANOTHER STICK INCIDENT. RCC RECEIVED A COMPLAINT VIA EMAIL. THERE WAS ANOTHER STICK INCIDENT WITH 382634, LOT 4242432, AT XXXXXXX. HAVE YOU ADVISED OUR XXXXXXXX TO PULL PRODUCT SINCE THERE SEEMS TO AN ISSUE WITH THIS LOT #? PLEASE PROVIDE THE DATE OF EVENT. 03/01/2025. 2. COULD YOU PLEASE PROVIDE MORE DETAILS ABOUT THE NEEDLE STICK INCIDENT? THERE WAS NO ¿STICK¿ INCIDENT. RN INSERTED IV. NEEDLE DID NOT RETRACT AFTER PRESSING THE BUTTON TO RETRACT THE NEEDLE. 3. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. NO PHOTOS. NEEDLE WAS DISCARDED IMMEDIATELY INTO SHARPS CONTAINER TO PREVENT ANY HARM. 4. ANY SAMPLE AVAILABLE FOR INVESTIGATION? NO SAMPLE OF THIS INDIVIDUAL ITEM. LOT NUMBER FROM PACKAGING IS 4242432. 5. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM OCCURRED TO STAFF OR PATIENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633937 BD INSYTE AUTOG BC WING PNK 20GA X1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4242432 00382903826346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown