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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.However, testing has not yet been completed.
Event or Problem Description
An event was reported that occurred between (b)(6) 2025 to (b)(6) 2025.The reporter stated that a 4.5" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, luer lock was leaking an unspecified fluid/infusate during patient use.There was no report of any human harm.There were 2 occurrences of the same issue/failure mode with the same list and lot number of the product.
Additional Manufacturer Narrative
Investigation summary: received two (2) used mc33371 smallbore bifuse ext set w/2 microclave for inspection.One (1) of the samples had the tubing separated from the microclave bond pocket.Examination of the bond area showed little to no solvent present.No defects or anomalies noted on the other sample.The set with no defects or anomalies noted was leak tested per product specifications.There was leakage from the tubing to bond pocket of the male luer.Examination of the leakage showed a tear in the tubing.The reported complaint of leakage can be confirmed on the two (2) samples.The probable cause of sample 1 is due to insufficient solvent applied during manual assembly.The probable cause of the other sample is due to an unintentional pulling force during use.A device history record 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: 22716147
• Report Number: 9617594-2025-01614
• Device Sequence Number: 18434104
• 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,Followup
• Report Date (Section B): 09/19/2025

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: MC33371
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID/INFUSATE, MFR UNK
• Patient Sex: Unknown