MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPC; STOPCOCK, I.V. SET

Catalog Number	AC135
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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event occurred on an unspecified date and involved a 120" (305 cm) appx 15.8 ml, 15 drop admin set w/3 clave¿ clear, nanoclave¿ stopcock, 2 check valves, spin luer, 2 ext where it was reported that one of the sets had some sort of black growth in the drip chamber.There was unknown patient involvement, unknown patient harm and unknown delay in therapy.
Additional Manufacturer Narrative
One used ac135 lot# 14082766 and one used ac135 lot# 14144071 were received for evaluation.Burnt embedded material was observed on the drip chamber of the set from lot# 14082766.The drip chamber was cut open and the material was confirmed to be embedded in the wall and not loose in the fluid path.No defects or anomalies noted on the other set.The reported complaint can be confirmed on the one used ac135 lot# 14082766.The probable cause is due to an error during molding in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPC
• Common Device Name: STOPCOCK, I.V. SET
• 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: 22054993
• Report Number: 9617594-2025-01058
• Device Sequence Number: 17171226
• Product Code: FMG
• UDI-Device Identifier: 00887709124417
• UDI-Public: (01)00887709124417(17)290901(10)14144071
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: AC135
• Device Lot Number: 14144071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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