BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMFORT

    MDR report key: 24232549 · Received February 2, 2026

    Report

    Report Number
    9611423-2026-00005
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 2, 2025
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    UDI-DI
    37290115921435
    PMA / PMN Number
    K192866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE ARE NOTIFYING YOU THAT WE HAVE RECEIVED ONE COMPLAINT, (B)(4) FROM OUR CUSTOMER REGARDING YOUR PRODUCT. SPIKE PORT ADAPTOR LEAKAGE; SPIKE LOOSE. MATERIAL-412166. BATCH-UBR522. NO SAMPLE. (B)(4). CUSTOMER (B)(4), (B)(6) OUTPATIENT PHARMACY. WHEN DID THE FAILURE OCCUR: DURING THERAPY. REASON OF COMPLAINT: IV SPIKE, (B)(4), CAME OUT WHEN ASSESSING SECURE CONNECTION ON ABRAXANE, MED SPILLED ON PUMP AND FLOOR. CLEANED SPILL AND NOTIFIED PHARMACY THAT A NEW BAG WAS NEEDED. NOTED. BASED ON DISPENSE PREPARATION IMAGES, APPEARS THAT ONGUARD2 BAG ADAPTOR WAS FULLY PUSHED INTO BAG PORT THOUGH ANGLES MAKE IT DIFFICULT TO CONFIRM WITH CERTAINTY. RESPONSE EXPECTED BY: CUSTOMER; COMPLAINT RECEIVER. ATTACHED INFORMATION: OTHERS. PRODUCTS RELATED TO COMPLAINT. MANUFACTURER OF DISPOSABLE: SIMPLIVIA. ARTICLE / BATCH: 412166/UBR522. MANUFACTURER OF DRUG: AMERICAN REGENT, INC. NDC 0517-4300-01. ARTICLE / BATCH: ALBUMIN BOUND PACLITAXEL150MG, EXP 07/27/LOT 90038F0021. OTHERS: ICU MEDICAL. ARTICLE / BATCH: 100ML EMPTY BAG/LIST NO. 7951-23. PATIENT INJURY-NO. ATTACHED INFORMATION- (B)(4) REGISTRATION FORM CUSTOMER COMPLAINT PICTURE, NO SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295392 CHEMFORT ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. UBR522 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown