MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC33371
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 4.5" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, luer lock that experienced breakage during use.The report stated, "nurse noticed broken bifuse in the patient's highchair".
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 1jul2025 has been used as a placeholder.E1 - additional contact (b)(6).Investigation summary: one (1) used partial.List #mc33371, 4.5" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, luer lock, two (2) used.List #unknown, extension tubing and two (2) used.List #unknown, extension set with clave and micron filter were returned for evaluation.As returned, the male luer of the mc33371 was observed to be separated and missing from the set.Additional the male luer from the unknown extension set was returned separated.The tube from the mc33371 was visually inspected and cut tube like the tube had been pulled was observed.The tube was measured finding shorter than specification.Complaint of broken can be confirmed.The probable cause is typically due to pulling force applied during use.A returned non icu set was observed with a tube separation.However, since this is an non-icu medical set the probable cause cannot be determined.A device history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK
• 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: 22795772
• Report Number: 9617594-2025-01669
• Device Sequence Number: 15532515
• Product Code: FMG
• UDI-Device Identifier: 00887709038172
• UDI-Public: 00887709038172
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: MC33371
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/13/2025
• 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 Sex: Unknown