MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC33332
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review was conducted, and no nonconformities were found that would have led to the reported complaint.Additional contact information: (b)(6), canada.
Event or Problem Description
An event involved a 128" (325 cm) appx 9.3 ml, transfer set w/microclave clear, dual check valve, smallbore bifuse ext set w/microclave clear (green ring), 0.2 micron filter, rotating luer reported that the patient had a peripheral iv (intravenous) for antibiotic administration and a typical bifuse extension set was used.On day shift it had been noted that the pump would occasionally ring off as line occluded, but alarm was resolved by repositioning baby's arm, they said that it was felt that it was likely a positional iv or an issue with the alaris pump itself as the iv site assessed well.On writer's shift, iv would ring occluded intermittently every few hours.The in-charge nurse continued to assess iv site, which looked perfect, and disconnected from iv extension set and was able to flush iv well.They disconnected lines from the pump and opened the clamp fully on the line to run fluid wide open to test the lines and no fluid came out.When they disconnected the d10w (dextrose) line from the green bifuse connection port, d10w fluid flowed freely.It appears there may have been a defect or issue with the line between the green bifuse port and the filter or perhaps an issue in the filter itself.There were patient involvement and no patient harm reported.

• Brand Name: 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: 24301216
• Report Number: 9617594-2026-00105
• Device Sequence Number: 5214975
• Product Code: FMG
• UDI-Device Identifier: 00887709037816
• UDI-Public: (01)00887709037816(17)300801(10)14553587
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: MC33332
• Device Lot Number: 14553587
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALARIS PUMP, UNK MFR; DEXTROSE 10W FLUID, UNK MFR; IV FOR ANTIBIOTIC, UNK MFR
• Patient Sex: Unknown