MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 12.3 ML, 15 DROP ADMIN SET W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B30010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a 100" (254 cm) appx 12.3 ml, 15 drop admin set w/rotating luer and it was reported that when the bag was spiked, it was leaking.This is happening usually within 10 minutes of infusion; this is being utilized for the neuro cases.This product is used with a pressure bag.The leaking is coming directly from where the bag is spiked.There was patient involvement, and no patient harm.
Additional Manufacturer Narrative
One photo was shared by customer, where drops of water are observed in many locations, in the filter vent cap, at the spike, at the top of an unknown set.No additional damage or anomalies were observed.Complaint of leaks can be confirmed based on the photo shared by customer.However, without the returned of the used sample, a comprehensive and probable cause of failure investigation cannot be performed and cannot be determined.The device history record was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 100" (254 CM) APPX 12.3 ML, 15 DROP ADMIN SET W/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: 24386496
• Report Number: 9617594-2026-00158
• Device Sequence Number: 10208389
• Product Code: FMG
• UDI-Device Identifier: 00887709003934
• UDI-Public: (01)00887709003934(17)300801(10)14526196
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: B30010
• Device Lot Number: 14526196
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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: 1000 HEPARIN SODIUM, UNK MFR; UNSPECIFIED PRESSURE BAG, UNK MFR
• Patient Sex: Unknown