MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 40" (102 CM) APPX 7.9 ML, ADMIN SET W/2 CHEMOLOCK® W/RED CAP, 20 DROP IN-LINE DR; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL4110
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	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 40" (102 cm) appx 7.9 ml, admin set w/2 chemolock® w/red cap, 20 drop in-line drip chamber, 0.2 micron filter, bag hanger.The customer reported that they found some type of residue inside the tubing just above the drip chamber.No patient involvement and no harm.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
D9 - date returned to mfr: 3/13/2026 received the following: one (1) opened/unused.List #cl4110, 40" (102 cm) appx 7.9 ml, admin set w/2 chemolock® w/red cap, 20 drop in-line drip chamber, 0.2 micron filter, bag hanger; lot #14448803.Four (4) new.List #cl4110, 40" (102 cm) appx 7.9 ml, admin set w/2 chemolock® w/red cap, 20 drop in-line drip chamber, 0.2 micron filter, bag hanger; lot #14448803.A white residue was observed on each sample.The reported complaint of residue could be confirmed.The returned samples were observed to have a white residue above the drip chamber.The probable cause is from errant solvent coverage during assembly in ensenada.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 40" (102 CM) APPX 7.9 ML, ADMIN SET W/2 CHEMOLOCK® W/RED CAP, 20 DROP IN-LINE DR
• 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: 24586172
• Report Number: 9617594-2026-00264
• Device Sequence Number: 9339568
• Product Code: ONB
• UDI-Device Identifier: 00887709090644
• UDI-Public: (01)00887709090644(17)300601(10)14448803
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: CL4110
• Device Lot Number: 14448803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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
• Patient Sex: Unknown