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
Four products were received for evaluation.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.The reported complaint of particulate matter could not be replicated or confirmed, as the evaluation of the returned sets did not confirm the presence of black specks.
Event or Problem Description
An event was reported on an unspecified date involving a secondary set, secure lock, 34 inch product.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: 25570126
• Report Number: 9617594-2026-00673
• Device Sequence Number: 21098514
• Product Code: FMG
• UDI-Device Identifier: 00887709095083
• UDI-Public: (01)00887709095083(17)310301(10)14892526
• 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: 14892526
• 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): Yes
• Date Device Manufactured: 03/03/2026
• 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