BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL

    MDR report key: 22474276 · Received July 10, 2025

    Report

    Report Number
    1710034-2025-01172
    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
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    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. ONE COMPLAINT FILED ADDRESSING TWO DIFFERENT DEVICES. IT IS NOT CLEAR WHICH DEVICE BROKE/SEPARATED, SO BOTH COMPLAINTS PROVIDE THE INFORMATION CONSERVATIVELY. SEE RELATED REPORT #. AT THIS TIME CUSTOMER HAS NOT REPLIED TO REQUEST FOR CLARIFICATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    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 381023. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316943 BD IAG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown