BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL

    MDR report key: 22474318 · Received July 10, 2025

    Report

    Report Number
    1710034-2025-01170
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 23, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810239
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381023 AND LOT NUMBER 4361619. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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 IAG BC PRO GLOBAL DEFECTIVE CATHETER BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION OF THE FACTS: THIS MORNING IN HDJ DERMATO / ALLERGO, DURING THE INSTALLATION OF THE CATHETER OF SEVERAL PATIENTS, DISCOVERED SEVERAL DEFECTIVE CATHETERS (2 PINK AND 1 BLUE) INCLUDING 1 CATHETER WHICH BROKE IN THE ARM OF THE PATIENT WHERE I MANAGED TO REMOVE EVERYTHING. PAIN/DISCOMFORT FOR THE PATIENT PRECAUTIONARY MEASURES AND ACTIONS TAKEN: DM NOT AVAILABLE FOR EXPERT APPRAISAL. YOU MENTIONED THAT SEVERAL PATIENTS WERE AFFECTED, COULD YOU CONFIRM THE NUMBER OF PATIENTS AFFECTED AND PROVIDE US WITH THE DATE OF THE EVENTS. THIS CONCERNS ONLY 1 CATHETER, AND THE INCIDENT OCCURRED ON (B)(6) 2025. THE LAST REPORTED INCIDENT IS REFERENCED (B)(4). THIS IS TO FIND OUT IF THE CATHETERS ARE DEFECTIVE OR IF THEY HAVE BEEN BROKEN AFTER THEY HAVE BEEN PLACED. COULD YOU PROVIDE US WITH THE DATE OF THE MOST RECENT INCIDENT? THE MOST RECENT INCIDENT OCCURRED ON (B)(6) 2025.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279873 BD IAG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4361619 00382903810239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown