MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 1.6 ML, BIFUSE EXT SET W/2 CHECK VALVES, 2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1690
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received a photo from the customer showing backflow in the sample.Received two used list # b1690, 7" (18 cm) appx 1.8 ml, bifuse ext set w/2 check valves, 2 clamps, rotating luer; lot #unknown.Visual: no visual damages or anomalies were observed.Functional: the samples were tested and were primed at gravity pressure.One sample primed with no issues.The other sample leaked through the check valve.Both samples were pressure leak tested at 25psi.One sample no leaks were observed.The other sample leaked through the same check valve that leaked during priming.Leakage was confirmed.The probable cause is due to a material issue on a vendor supplied part.There is an ongoing capa related to this complaint issue at this time.Device history records were reviewed for potential lot numbers (14051773 or 13951434), no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The complaint/event involved a 7" (18 cm) appx 1.6 ml, bifuse ext set w/2 check valves, 2 clamps, rotating luer.During complaint investigation, one used/returned device failed testing after it was primed at gravity pressure.The device leaked through the check valve when it was pressure leak tested at 25psi during priming.

• Brand Name: 7" (18 CM) APPX 1.6 ML, BIFUSE EXT SET W/2 CHECK VALVES, 2 CLAMPS, 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: 22127842
• Report Number: 9617594-2025-01139
• Device Sequence Number: 8906899
• Product Code: FMG
• UDI-Device Identifier: 00887709084612
• UDI-Public: 00887709084612
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: B1690
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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