MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	MC3316
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 7" (18cm) appx 0.37ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer generated a leak during patient use.The reporter stated that the y-site connector for intravenous (iv) tubing was leaking.Blood was backing up from a femoral central venous line (cvl) into the tubing iv, and then it was noted that there was blood on the bedsheets.Upon tracing the lines, a leak was found at the bifurcation of a y-site connector tubing.The impact of the incident was a scant amount of blood loss, small amount of medication not administered via continuous infusion, increased risk of infection.The number of defective devices is one.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Additional Manufacturer Narrative
Received one (1) used list# mc3316, 7" (18cm) appx 0.37 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer: lot# 14040948.The reported complaint of a leak could be confirmed.A leak was observed in the tubing during testing.The tubing was observed to have a hole.The probable cause of the leak is from a sharp object during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS,
• 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: 20694769
• Report Number: 9617594-2024-01617
• Device Sequence Number: 17083017
• Product Code: FMG
• UDI-Device Identifier: 00887709037458
• UDI-Public: (01)00887709037458(17)290601(10)14040948
• 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): 01/06/2025

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: MC3316
• Device Lot Number: 14040948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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