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; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CL3020
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint 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.An unidentified white substance was reported in the tube or there was visible white substance in fluid path.There was no patient harm.
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been checked in as received.
Additional Manufacturer Narrative
D9 - date returned to mfg: 10/15/2025.Received two (2) new 011-cl3020 admin set w/chemolock for inspection.Solvent was observed at the tubing above the drip chamber on each sample.The solvent fluoresced under uv light.The solvent was attached and not loose.The complaint of white on the tubing can be confirmed.The probable cause is due to errant solvent applied during manual assembly in manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 23409165
• Report Number: 9617594-2025-02076
• Device Sequence Number: 12991565
• Product Code: FPA
• UDI-Device Identifier: 00887709072923
• UDI-Public: (01)00887709072923(17)300701(10)14504687
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 14504687
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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