MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 39" (99 CM) APPX 5.3 ML, EXT SET W/3-WAY STOPCOCK, REMV 4-WAY STOPCOCK, CLAMP, R; STOPCOCK, I.V. SET

Catalog Number	B4177
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of backflow of fluid/bleedback on item b4177 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The dhr lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.
Event or Problem Description
A medsun mandatory medwatch report with uf/importer report# (b)(4) email was received regarding a39" (99 cm) appx 5.3 ml, ext set w/3-way stopcock, remv 4-way stopcock, clamp, rotating luer, 1 ext.It was reported that they placed an iv and attempted to connect to extension tubing.Blood and unspecified iv fluids started back flowing out of the connections.Everything was connected properly but continued to spray out.New tubing was attached.The fluids and blood did get on the nurse's skin and shirt as well as the stretcher and patient.There was patient involvement and no patient harm and no delay in therapy.The complaint record indicates that reported issue occurred on an unspecified date in august 2025.

• Brand Name: 39" (99 CM) APPX 5.3 ML, EXT SET W/3-WAY STOPCOCK, REMV 4-WAY STOPCOCK, CLAMP, R
• 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: 23385334
• Report Number: 9617594-2025-02047
• Device Sequence Number: 8718350
• Product Code: FMG
• UDI-Device Identifier: 00887709071643
• UDI-Public: (01)00887709071643(17)300301(10)14331820
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: B4177
• Device Lot Number: 14331820
• 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: 09/26/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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: UNSPECIFIED IV FLUIDS, MFR UNK; UNSPECIFIED IV LINE, MFR UNK
• Patient Sex: Unknown