MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.38 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP; STOPCOCK, I.V. SET

Catalog Number	MC330359
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that with the smallbore bifuse extension set with 2 microclave® clear, 2 clamps (white, blue), luer lock.The patient's line was noted to be leaking.Upon further inspection the white port of bifuse noted to be leaking.The pump showed high pressure but had not alarmed.There was patient involvement and there was a delay in therapy.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary when additional reportable information becomes available.
Additional Manufacturer Narrative
Investigation summary: received the following: one (1) used.List #mc330359, 8" (20 cm) appx 0.38 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps (white, blue), luer lock.; lot #14271029.One (1) new.List #mc330359, 8" (20 cm) appx 0.38 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps (white, blue), luer lock.; lot #14271029.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed on the microclave on the line with a white clamp.The microclave was disassemble and was found to have a crushed spike and a torn seal.The probable cause is from the use of an incompatible mating device.The directions for use states: the clave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" (20 CM) APPX 0.38 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP
• 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: 22135825
• Report Number: 9617594-2025-01144
• Device Sequence Number: 12850559
• Product Code: FMG
• UDI-Device Identifier: 00887709085282
• UDI-Public: (01)00887709085282(17)300101(10)14271029
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: MC330359
• Device Lot Number: 14271029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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: LARONIDASE.
• Patient Sex: Unknown