BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOSAFELOCK BAG SPIKE

    MDR report key: 21894336 · Received April 23, 2025

    Report

    Report Number
    9617594-2025-00818
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 24, 2025
    Report Date
    July 1, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A COUPLE OF PHOTOS WERE SHARED BY CUSTOMER, WHERE A SMALL PIECE OF BROWN PARTICULATE IS OBSERVED DEEP IN THE VIAL. CUSTOMER SHOWS A FTIR RESULTS WERE THE REFERENCE SHOWS A CELLULOSE MATERIAL; NO ADDITIONAL DAMAGE OR ANOMALIES ARE OBSERVED. ONE USED LIST# KL-BS001U3, CHEMOSAFELOCK BAG SPIKE AND PETRI DISH WERE RETURNED FOR EVALUATION. AS RECEIVED A SMALL BROWN PARTICULATE INSIDE WAS RETURNED, THE RETURNED ITEM WAS VISUALLY INSPECTED, LOOKING FOR POTENTIAL SOURCE OF THE PARTICULATE, NO GROOVES, FLASH OR SCRATCHES WERE OBSERVED. LOOKING THE FTIR RESULTS ATTACHED BY CUSTOMER, THE BROWNISH PARTICLE NOTED AT THE BOTTOM PART OF THE IV BOTTLE MAKE REFERENCE TO A CELLULOSE. BASED ON THE ITEM SET CONFIGURATION, NO CELLULOSE MATERIAL WAS USED IN ANY OF OUR MANUFACTURING PROCESS. THE COMPLAINT OF PARTICULATE MATTER CAN BE CONFIRMED. HOWEVER, BASED ON THE FTIR THE RESULTS WAS CELLULOSE PARTICULATE LOOKS TO BE FIBER MATERIAL SUCH CARTOON, THIS PARTICULATE DOES NOT HAVE ANY COMPONENT FROM THE MANUFACTURING PROCESS THAT MATCHES WITH THIS. THE SOURCE IS UNKNOWN. THE LOT HISTORY WAS REVIEWED; NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. CORRECTED INFORMATION IN D2, D3, AND G4.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, TESTING HAS NOT YET BEEN COMPLETED. ADDITIONAL CONTACT: RUMI FUKUZAWA TERUMO CORPORATION KOFU FACTORY 1727-1 TSUIJIARAI SHOWA CHO, NAKAKOMA GUN YAMANASHI PREF, 409-3853 [email protected].

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE. FOREIGN MATTER WAS REPORTED AT THE BOTTOM PART OF THE INTRAVENOUS BOTTLE WHEN THE DEVICE WAS CONNECTED TO A 100ML SALINE BOTTLE AND BEVACIZUMAB BS, WHICH WAS PREPARED USING A KL-VA001U3 AND A KL-MSU3, WAS CONNECTED TO THE KL-BS001U3 TO INJECT THE PREPARED SOLUTION INTO SALINE BAG. A BROWN FOREIGN SUBSTANCE, MEASURING APPROX. 3MM IN LENGTH, WAS FOUND INSIDE THE SALINE BOTTLE. ONE ACTUAL SAMPLE (KL-BS001U3) WAS RECEIVED CONNECTED TO A SALINE BOTTLE (100ML/OTSUKA). IN ADDITION, ONE(1) KL-MSU3 CONNECTED TO A 20ML SYRINGE, AND ONE(1) KL-VA001U3 CONNECTED TO A VIAL BOTTLE OF BEVACIZUMAB BS (DAIICHI SANKYO). EACH INDIVIDUAL PACKAGE WAS ALSO RETURNED TO THE TERUMO KOFU FACILITY. UPON CLOSELY CHECKING THE SALINE BOTTLE, BROWNISH FOREIGN MATTER WAS VISIBLY SUSPENDED. THE FOUND FOREIGN MATTER MEASURED APPROXIMATELY 2.8MM X 0.6MM AND WAS FIBER-LIKE IN NATURE. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) WAS PERFORMED ON THE FOUND FOREIGN MATTER BY TERUMO. THE RESULT OF THE TESTING SHOWED A SIMILAR SPECTRUM TO CELLULOSE. TERUMO CLOSELY CHECKED THE ADDITIONAL SAMPLES RECEIVED WITH THE KL-BS001U3 AND NO FOREIGN MATTERS WERE OBSERVED. THE EVENT WAS DETECTED PRIOR TO DIRECT PATIENT USE AND WAS NOTED DURING DRUG PREPARATION OF BEVACIZUMAB BS, 100ML SALINE BOTTLE. THERE WAS NO SERIOUS INJURY/DEATH, NO ADVERSE OPERATOR CONSEQUENCES, NO UNPROTECTED CHEMO EXPOSURE AND NO MEDICAL/SURGICAL INTERVENTION WERE REQUIRED. THE DEVICE WAS CHANGED WITH NO FURTHER PROBLEMS ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258452 CHEMOSAFELOCK BAG SPIKE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14088665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 100ML SALINE BOTTLE, MFR UNK| BEVACIZUMAB BS, MFR (B)(4)| CHEMOSAFELOCK CONNECTER, REF #KL-MSU3, MFR ICU MED| CHEMOSAFELOCK VIAL ADPTR, REF #KL-VA001 MFR ICUMED| UNSPECIFIED BLUE CLAVE, MFR UNK| UNSPECIFIED INTRAVENOUS BOTTLE, MFR UNK| UNSPECIFIED SYRINGE, MFR UNK