MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33213
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A series of photos were shared by customer, where customer is showing the affective item, however no significant damage, leaks or anomalies were noted.One used list # mc33213 was returned for evaluation.A crack on the female luer was observed.No mating device was returned for evaluation.The returned set was tested and a leaks from a crack on the female luer was observed.Complaint of leaks can was able to be replicated.The probable cause is due to a material issue on a vendor supplied part.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Additional reporters: (b)(6).
Event or Problem Description
Leakage was reported from a 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer device.It was reported that a midline iv catheter was inserted into patient, and the product was attached to end of the line for purposes of flushing.Leakage of fluid from extension set was then identified from a small crack near remv microclave.The device was removed from the line and replaced with another, functional ext.Set.There were no harm and no delay in care.

• Brand Name: 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI
• 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: 23404677
• Report Number: 9617594-2025-02063
• Device Sequence Number: 4927819
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: (01)00887709037519(17)290701(10)14073123
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: MC33213
• Device Lot Number: 14073123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED (FLUSHING) FLUID, MFR UNK; UNSPECIFIED MIDLINE IV CATHETER, MFR UNK
• Patient Sex: Unknown