MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 1.2 ML, BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS (2 WHIT; STOPCOCK, I.V. SET

Catalog Number	MC33717
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2024 has been used as a placeholder.Customer gave a time range rather than a date in 2024.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with regards to 7.5" (19 cm) appx 1.1 ml, bifuse ext set w/2 microclave¿ clear, 3 clamps (2 white, blue), luer lock that experienced breakage and leakage.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." "patients did not suffer harm as these were found quickly, but the patient¿s did lose blood and chemo was also spilled".
Additional Manufacturer Narrative
Investigation summary: received one (1) used.List #mc33717, 7.5" (19 cm) appx 1.1 ml, bifuse ext set w/2 microclave¿ clear, 3 clamps (2 white, blue), luer lock.As received, the returned sample is missing the male luer, no other damage or anomalies were observed.Some solvent was present on the tubing of the set.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" (19 CM) APPX 1.2 ML, BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS (2 WHIT
• 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: 21339717
• Report Number: 9617594-2025-00244
• Device Sequence Number: 8550038
• Product Code: FMG
• UDI-Device Identifier: 00887709064829
• UDI-Public: 00887709064829
• 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
• 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: MC33717
• 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: 02/18/2025
• Initial Report FDA Received Date: 02/07/2025
• 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