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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 4.5" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, luer lock where it was reported that the bifuse was cracked and leaking into isolette.There was patient involvement and no adverse events.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.
Additional Manufacturer Narrative
Received two (2) used.List #mc33371, 4.5" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, luer lock for insepction.One sample had a microclave separated from the tubing.The other sample had the luer lock separated from the tubing.Examination of the bond showed little solvent on the tubing to microclave pocket bond interface.There was insufficient solvent on the separated luer and tubing.The tubing and bond pocket on both samples were measured and both were found to be within design specifications.Subsequent bond integrity testing on an adjacent bond met performance expectations.The reported complaint of bifuse cracked and leaking can be confirmed.The probable cause is insufficient solvent coverage during manual assembly in ensenada.A device history review (dhr) lot # 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: 22351077
• Report Number: 9617594-2025-01375
• Device Sequence Number: 20964231
• Product Code: FMG
• UDI-Device Identifier: 00887709038172
• UDI-Public: (01)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,Followup
• Report Date (Section B): 10/03/2025

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?: Yes
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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