BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC PNK

    MDR report key: 18896731 · Received March 13, 2024

    Report

    Report Number
    1710034-2024-00181
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    December 1, 2023
    Report Date
    July 31, 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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED IN B5. INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382533 AND LOT NUMBER 3083898. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC PNK NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE DID NOT RETRACT. SAFETY ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. NO THERE WAS NO PATIENT IMPACT, THERE WAS LUCKILY NO NEEDLE STICK ISSUES FOR THE EMPLOYEE AS WELL, THOUGH IT POSED A SIGNIFICANT RISK FOR THIS. DID THE EVENT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181584 BD INSYTE AUTOG BC PNK PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3083898 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown