MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3528
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding a 30" (76cm) appx 6.3 ml, 20 drop admin set w/integrated chemolock port drip chamber, 0.2 micron filter, chemolock w/red cap, hanger where it was reported that filter set drawing air post filter for an infusion after it had been running for 3 hours.This event occurred during hour 3 of administration.There were 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
Investigation summary: received one (1) used.List # cl3528, 30" (76cm) appx 6.3 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, 0.2 micron filter, chemolock¿ w/red cap, hanger; lot # unknown.The reported complaint of air in line could not be confirmed.The returned sample was tested and air in line could not be replicated.A device history review could not be could not be conducted because no lot number(s) was/were identified.

• Brand Name: 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA
• 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: 24444807
• Report Number: 9617594-2026-00195
• Device Sequence Number: 10307837
• Product Code: ONB
• UDI-Device Identifier: 00887709057043
• UDI-Public: 00887709057043
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: CL3528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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