MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 109" (277 CM) APPX 13 ML, 60 DROP PRIMARY SET W/CLAVE, 4-WAY STOPCOCK, ROTATING; STOPCOCK, I.V. SET

Catalog Number	B33945
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.Possible lot number 14790905: expiration date: 11/01/2030; mfg date: 11/22/2025.
Event or Problem Description
An event was reported on an unspecified date involving a 109-inch (277 cm), approximately 13.3 ml, 60-drop primary set with clave, 4-way stopcock, rotating luer, and one small-bore extension.It was reported that there were black specks in the drip chambers.There was no reported patient involvement or patient harm.

• Brand Name: 109" (277 CM) APPX 13 ML, 60 DROP PRIMARY SET W/CLAVE, 4-WAY STOPCOCK, ROTATING
• 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: 25570239
• Report Number: 9617594-2026-00675
• Device Sequence Number: 5213690
• Product Code: FMG
• UDI-Device Identifier: 00887709095083
• UDI-Public: (01)00887709095083
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2026

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: B33945
• Device Lot Number: PLOT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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