BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOLOGY KIT W/12" EXT SET, SPIROS® W/RED CAP, CLAMP, GRADUATED ADAPTER; CHEMOCL

    MDR report key: 25191824 · Received May 15, 2026

    Report

    Report Number
    9617594-2026-00460
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00887709082632
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT - THE DATE OF EVENT IS UNKNOWN, AND 01APR2026 HAS BEEN USED AS A PLACEHOLDER. D1 - BRAND NAME: ONCOLOGY KIT W/12" EXT SET, SPIROS® W/RED CAP, CLAMP, GRADUATED ADAPTER; CHEMOCLAVE® VENTED VIAL SPIKE, 20MM; CHEMOCLAVE® VENTED VIAL SPIKE, 13MM; SPIROS® W/RED CAP THE DEVICE HAS BEEN REQUESTED FOR EVALUATION- IT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    AN EMAIL WAS RECEIVED REGARDING AN ONCOLOGY KIT WITH12 EXT SET, SPIROS WITH RED CAP, CLAMP, GRADUATED ADAPTER; CHEMOCLAVE VENTED VIAL SPIKE, 20MM; CHEMOCLAVE VENTED VIAL SPIKE, 13MM; SPIROS WITH RED CAP IN WHICH IT WAS REPORTED THAT ON UNSPECIFIED DATES MULTIPLE INFUSION SETS FROM THE KIT BROKE RESULTING IN NO FLOW. DURING INFUSION, THE MEDICATION DID NOT DELIVER PROPERLY, AS THE PLUNGER BECAME STUCK IN THE DOWN POSITION AND WOULD NOT DISENGAGE, PREVENTING FURTHER USE OR REATTEMPT. MULTIPLE SIMILAR INCIDENTS HAVE BEEN IDENTIFIED, AND THESE FAILURES APPEAR TO BE ASSOCIATED WITH THE SAME LOT NUMBER. ALL PATIENT TREATMENTS WERE ULTIMATELY COMPLETED; HOWEVER, IN SEVERAL INSTANCES, IT WAS NECESSARY TO SWITCH TO A DIFFERENT GRAVITY KIT OR TRANSITION TO A PUSH KIT DUE TO DEVICE MALFUNCTION. THE THERAPY ADMINISTERED WAS BACILLUS CALMETTE-GUÉRIN (BCG) TREATMENT, MANUFACTURED BY MERCK SHARP & DOHME. THERE WERE A PATIENT INVOLVEMENT AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372538 ONCOLOGY KIT W/12" EXT SET, SPIROS® W/RED CAP, CLAMP, GRADUATED ADAPTER; CHEMOCL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14859771 00887709082632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BACILLUS CALMETTE-GUÉRIN, MERCK