MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 0.59 ML, SMALLBORE BIFUSE EXT SET, W/CLAVE¿, CHECK VALVE, 2 CL; STOPCOCK, I.V. SET

Catalog Number	B33983
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.Investigation summary: two (2) photos were shared by the customer, unable to confirm customer complaint of leaking from the photos provided.Received 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.As received no significant visual damage or anomalies were observed.The sample was tested per specification, and a leak was coming from between the shunt and tapered connection of the trifurcated connector was observed.The bond where the leak was observed was separated and insufficient solvent coverage in the tapered connection of the trifurcated connector was observed.A dhr lot# review could not be conducted because no lot number(s) was/were identified.This complaint can be confirmed.The probable cause is due to insufficient solvent application during assembly process in ensenada.
Event or Problem Description
A complaint was received regarding a 6.5" (17 cm) appx 0.59 ml, smallbore bifuse ext set, w/clave¿, check valve, 2 clamps (red, white), that experienced leakage.The report stated that the device is leaking.Sample photos are provided.There was unknown patient involvement and unknown patient harm.
Event or Problem Description
Received additional information: the reporter stated that they have defective products that are still on hand.There was unknown delay in therapy reported.The total affected product were 16 cases.
Additional Manufacturer Narrative
Additional information in b5.

• Brand Name: 6.5" (17 CM) APPX 0.59 ML, SMALLBORE BIFUSE EXT SET, W/CLAVE¿, CHECK VALVE, 2 CL
• 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: 21639159
• Report Number: 9617594-2025-00506
• Device Sequence Number: 12438963
• Product Code: FMG
• UDI-Device Identifier: 00887709127166
• UDI-Public: 00887709127166
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: B33983
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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