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	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation however a device history review should be performed, investigation pending.
Event or Problem Description
An incident involving 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 1 of 2 events reported that filter sets drawing air post filter greater than 8 hours after the infusion has been started on some of their extended infusions.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• 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: 23786125
• Report Number: 9617594-2025-02300
• Device Sequence Number: 5570670
• Product Code: ONB
• UDI-Device Identifier: 00887709057043
• UDI-Public: (01)00887709057043(17)270101(10)5782845
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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
• Device Lot Number: 5782845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2022
• 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