MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CH3011
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During hazardous drug compounding, an icu medical chemo clave spiros device became unlatched after connection to the iv bag, allowing approximately 5 ml of chemotherapy solution to spill onto the hood work surface.The syringe was promptly re-secured to stop the flow, the device was safely disconnected, and the spill was cleaned and decontaminated per protocol.No exposure outside the hood occurred.This has been an ongoing problem reported by the pharmacy to the icu medical team.Devices identified: (3 devices).Icu medical: 30" (76cm) appx 3.3ml, 20 drop admin set with integrated chemoclave drip chamber, spiros.With red cap, bag hanger.(b)(4).Ref ch3011, (b)(4).(10) multiple lot numbers.Icu medical chemoclave universal vented vial spike.Ref: ch-70 (b)(4), (10) multiple lot numbers.Icu medical: spiros closed male luer w/red cap, 10 units.Ref ch2000sc-10 (b)(4), (10) multiple lot numbers.

• Brand Name: ICU MEDICAL
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 24980419
• Report Number: 24980419
• Device Sequence Number: 15863612
• Product Code: ONB
• UDI-Device Identifier: 00840619023966
• UDI-Public: (01)00840619023966(17)310101(30)01(10)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/17/2026
• Report Date (Section F): 04/17/2026

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
• Device Model Number: CH3011
• Device Catalogue Number: CH3011
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/17/2026