MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B9286
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, on an unspecified date, a 112" (284 cm) appx 14.4 ml, 15 drop primary set w/3 microclave, rotating luer was found to be contaminated.It was reported that the product had been contaminated in the fluid path.There was no patient harm reported.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
One photo and one unused device was returned for investigation.The device was visually inspected.A red stain in the drip chamber plastic was noted, the contamination was rubbing and it was confirmed that was embedded inside the plastic material.Complaint of particulate matter can be confirmed, the probable cause was an error during costa rica molding process.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 1/13/2026.Updated information in d9 - device available for evaluation.

• Brand Name: 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER
• 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: 23855521
• Report Number: 9617594-2025-02320
• Device Sequence Number: 10388940
• Product Code: FMG
• UDI-Device Identifier: 00840619045876
• UDI-Public: (01)00840619045876(17)300801(10)14550430
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• 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: B9286
• Device Lot Number: 14550430
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown