MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.77 ML, SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	B1701
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Event or Problem Description
It was reported that the 4" (10 cm) smallbore trifuse ext set w/2 remv check valves, 3 clamps (red, yellow, white), luer lock, non dehp tubing had a leak issue.It was stated that the device started to leak at the junction with flushing.The status of the product at the time of event was during patient use.Information on specific fluid or medication is not available.There was patient involvement, no adverse event and possible delay in therapy due to having to replace line/extensions.
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where an unknown residual on the male luer's threads is observed, is not clear how or when this condition happened based on the photo.One (1) used list# b33980, one (1) used list# b33980, 5" (13 cm) appx 0.83 ml smallbore trifuse ext set w/2 clave¿, 2 check valves, 3 clamps (red, yellow, white), luer lock; lot #unknown.À two (2) used.List #unknown, clave; lot #unknown.Attached to (1) used.List #unknown, 5 ml sodium chloride syringe; lot #unknown.As received no significant visual damage or anomalies were observed.(a6) one (1) used list# b33980, one (1) used list# b33980, 5" (13 cm) appx 0.83 ml smallbore trifuse ext set w/2 clave¿, 2 check valves, 3 clamps (red, yellow, white), luer lock, connected to an unknown microclave were returned for evaluation.As received no physical damage or anomalies were observed.(a9).The samples were tested per specification, and a leak was coming from between the shunt and tapered connection of the trifurcated connector was noted.The bond where the leak was observed was separated and an insufficient solvent coverage in the tapered connection of the trifurcated connector was found.(a6) (a9) this complaint can be confirmed.The probable cause is due to insufficient solvent application during assembly process.The device history lot review couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: 4" (10 CM) APPX 0.77 ML, SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAM
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21049010
• Report Number: 9617594-2024-01918
• Device Sequence Number: 3278981
• Product Code: FMG
• UDI-Device Identifier: 00887709068476
• UDI-Public: (01)00887709068476
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/06/2025

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: B1701
• Device Lot Number: UNKNOWN
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 04/06/2025
• 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