MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.38 ML SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, CHECK VA; STOPCOCK, I.V. SET

Catalog Number	MC33691
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event involved a 4" (10 cm) appx 0.49 ml smallbore bifuse ext set w/2 microclave¿ clear, check valve, 2 clamps (red,white), rotating luer where it was reported the iv line broke at the cap of the extension set.Mom clamped central venous line (cvl), small amount of blood loss (no greater than 10ml).The event occurred during continuous infusion of normal saline.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
Received one used.List #mc33691, 4" (10 cm) appx 0.49 ml smallbore bifuse ext set w/2 microclave¿ clear, check valve, 2 clamps (red,white), rotating luer; lot #uknown.A microclave was observed to be missing on the bifuse.The microclave was not returned.The reported complaint the iv line breaking could be confirmed.The returned sample was observed to be missing a microclave.The probable cause is from insufficient solvent coverage during assembly.A device history lot number could not be conducted because no lot number(s) was/were identified.

• Brand Name: 4" (10 CM) APPX 0.38 ML SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, CHECK VA
• 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: 22036272
• Report Number: 9617594-2025-01024
• Device Sequence Number: 8492907
• Product Code: FMG
• UDI-Device Identifier: 00887709064317
• UDI-Public: 00887709064317
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: MC33691
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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