MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3020
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Investigation is pending.
Event or Problem Description
The event occurred during various dates between 15-aug-2025 to 18-aug-2025 and involved a 40" (102 cm) appx 4.9 ml, admin set w/chemolock¿ w/red cap, 20 drop in-line drip chamber, spiros®, bag hanger, drop-in red cap where it was reported there was an unidentified white substance in tube.The issue was identified when the registered nurse (rn) was priming the tubing with chemotherapy for a specific patient.There was no patient involvement and no adverse event.
Additional Manufacturer Narrative
Investigation summary received the following: one (1) open/unused.List #cl3020, 40" (102 cm) appx 4.8 ml, admin set w/chemolock¿ w/red cap, 20 drop in-line drip chamber, spiros¿, red cap, bag hanger; lot #14479820.Two (2) new.List #cl3020, 40" (102 cm) appx 4.8 ml, admin set w/chemolock¿ w/red cap, 20 drop in-line drip chamber, spiros¿, red cap, bag hanger; lot #14391940 as received, the sets were inspected with uv light, and the presence of solvent at the bond connection with the chemolock and the drip chamber in all the sets was confirmed.The complaint of unidentified white substance in tube can be confirmed.The probable cause, an errant solvent during manual assembly process in the assembly plant.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint corrective and preventative actions are in process.

• Brand Name: 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23019659
• Report Number: 9617594-2025-01829
• Device Sequence Number: 10038427
• Product Code: ONB
• UDI-Device Identifier: 00887709072923
• UDI-Public: (01)00887709072923(17)300401(10)14391940
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CL3020
• Device Lot Number: 14391940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY, UNK MFR.
• Patient Sex: Unknown