MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33150
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
The event involved a 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave® clear, purple clamp, rotating luer where it was reported that blood found in closed system iv extension system.The blood got into the microclave cap of the iv extension set while being used in conjunction with an arterial line.Changing the microclave extension set was risky for the 23-week gestation infant.The microclave extension set was connected directly to the arterial line.There was a small crack in the microclave cap.There was reported patient involvement and no reported patient harm.
Additional Manufacturer Narrative
D9 - date returned to mfg: 10/16/2025.Two (2) photos were returned showing the mc33150 in one (1) photo.The other photo had a set not related to the complaint.Received one (1) used mc33150 smallbore pressure infusion (400psig) ext set w/microclave for inspection.Blood residuals were observed inside of the housing of the microclave.No mating devices were returned.The mc33150 was leak tested per product specifications.There was no leakage.The microclave was disassembled, and the windows of the internal spike were found to be compressed.No cracks were found.The reported complaint of leakage can be confirmed.The probable cause of the damage to the internal spike and leakage is due to access with an incompatible mating device.The dfu states: "connectors are compatible with iso male luers having an internal diameter between 0.062¿ (1.55mm) and 0.110¿ (2.8 mm).".

• Brand Name: 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 23316921
• Report Number: 9617594-2025-02004
• Device Sequence Number: 12212929
• Product Code: FPA
• UDI-Device Identifier: 00887709037441
• UDI-Public: (01)00887709037441
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100576
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: MC33150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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 Age: 5 MO
• Patient Sex: Unknown