MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER; STOPCOCK, I.V. SET

Catalog Number	MC33722
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received with regards to 7.5" trifuse ext set w/3 microclave® clear, 4 clamps (2 white, blue, red), luer lock that experienced breakage and leakage during use.Report 1 of 2.The reporter stated that "all the breaks happened where the male luer lock inserts into the patient¿s microclave cap.They think it may be a bonding issue.This resulted in blood loss and ivf loss for the patients, chemo spills, and can potentially cause great harm for the patients." medwatch #(b)(4) ¿patient was found with blood on their gown.The trifuse iv administration set luer connection had detached from the patient end of the tubing.It appears to be a bonding issue at the connection.¿ chemotherapy was being used on the patient at the time of the event and date of chemotherapy is (b)(6)2024.The original intended procedure was iv fluid administration.The problem that the user have was device failed (e.G.Broke, couldn't get it to work or stopped working).Additionally, the customer stated that "patients did not suffer harm as these were found quickly, but the patient¿s did lose blood and chemo was also spilled".Product¿s were in use, providing drug treatment at time of incidents.Ivf was not an icu medical product.
Additional Manufacturer Narrative
A2 - date of birth - the patients age was used to approximate the date of birth as (b)(6) 2004.B3 - date of event - the date of event is specified beyond nov 2024; therefore, 01 nov 2024 has been used as a placeholder.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Correction: e4 initial report sent to fda - yes additional information/correction: h10 - added medwatch number.
Additional Manufacturer Narrative
Investigation summary two (2) used.List #mc33722, 7.5" trifuse ext set w/3 microclave® clear, 4 clamps (2 white, blue, red), luer lock; lot #unknown.Were received and evaluated.As received, the male luer of the extension set was separated from the tubing.Some solvent was present on the tubing of the set.A pull test was performed on a comparable bond on sample 2 extension set.The tubing pulled out within specification.A solvent ring similar to the solvent identified on the tubing that was separated (sample 1) as received was seen.The reported complaint of a separation can be confirmed.The probable cause of the tubing separation is insufficient solvent during assembly in ensenada.A device history record lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), 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: 21339549
• Report Number: 9617594-2025-00242
• Device Sequence Number: 11724858
• Product Code: FMG
• UDI-Device Identifier: 00887709064942
• UDI-Public: 00887709064942
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: MC33722
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 01/10/2025; 02/18/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/07/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 20 YR
• Patient Sex: Male
• Patient Weight: 62 KG