MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	011-MC3316
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown but in april, and 01 apr 2025 has been used as a placeholder.E1: initial reporter phone number: (b)(6).The area code was not provided and not assumed.The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding a 6" (15cm) appx 0.33ml, smallbore bifuse ext set w/2 microclave® clear, 3 clamps, rotating luer that experienced crack and leakage.This is report 2 of 2 for the unknown date in (b)(6).The reporter stated that " the adult general icu at bristol royal infirmary use the 6 inch (15cm) smallbore bifuse extension sets with 2 microclave clear adaptors and 3 clamps with rotating luer lock product ref 011-mc-3316.They have had x2 of these adaptors cracked and leaking below the microclave adaptor at the actual lumen of the line- these were new adaptors and found to be leaking reported to mhra this evening as x2 failed adaptors found in the last week- batch number /lot 14153009.This is a high-risk event as an icu we administer life preserving and saving medications through these adaptors and it is very unusual to have had two adaptors fail at the same point in the last week ¿.Update: the incident happened on (b)(6) 2025.This is a high-risk with the connectors as critical medications not administered- due to a split in the material.There was a patient involvement but no patient harm but potential for life saving medications to leak out and not be administered.
Additional Manufacturer Narrative
Received two (2) used 011-mc3316 ext set smallbore bifuse w/2 clave for inspection.One (1) of the microclaves on one set had fluid inside of the housing, indicative of internal leakage.Each set was leak tested per product specifications.There was leakage from one (1) of the sets from the microclave.The internal seal was found to have excessive tearing that propagated to the side wall.The reported complaint of leakage can be confirmed due to the torn seal.The probable cause of the torn seal is due to access with an incompatible mating device.The directions for use states: the clave / microclave connector is compatible with luers with an internal diameter (id) between 1.55 mm and 2.8 mm.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 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: 22100303
• Report Number: 9617594-2025-01114
• Device Sequence Number: 8448025
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)290901(10)14153009
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/03/2025

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: 011-MC3316
• Device Lot Number: 14153009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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