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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 4" (10 cm) appx 0.77 ml, smallbore trifuse ext set w/2 remv check valves, 3 clamps (red, yellow, white), luer lock where the customer reported that the device was cracked and leaking.There was patient involvement, no adverse event and possible delay in therapy due to having to replace line/extensions.Information on specific fluid or medication is not available.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
Additional information: d9 - date returned to mfg: 12-dec-2024 investigation summary one (1) photo was shared by the customer, where a microclave is connected with a female luer.However, no cracks, leaks or anomalies are observed based on the photo.One (1) photo was shared by the customer, where a microclave is connected with a female luer.However, no cracks, leaks or anomalies are observed based on the photo.Two (2) 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, attached to an unknown microclave.As received, sample a12 was separated from the trifurcated connector, sample a11 did not present any damage or anomalies.Further inspection of the bond location showed spotty solvent application (a12).After test sample a12 a leak between shunt and tapered connection on trifurcated connector was found, this passed the pull test.Complaint of leak can be confirmed.The probable cause of the leak and separation on sample a12 was due to insufficient solvent application during assembly process in ensenada.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21047351
• Report Number: 9617594-2024-01903
• Device Sequence Number: 8484555
• 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
• 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): 03/19/2025

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: 02/19/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/19/2025
• 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