MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.69 ML, EXTENSION SET, CLAVE¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33257
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer-reported event involved a 7" smallbore pressure infusion (400psig) bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer.The iv locks were cracked vertically in three places of the device.A crack was identified horizontally across the base while attaching to patient, leading to blood leakage.The device was cleaned, and then they noticed the cracks in the saline lock and the blood leakage continued.The intravenous (iv) lock was replaced immediately for the patient.There was no reported human harm.
Additional Manufacturer Narrative
Received a series of photos from the customer showing the affected sample.The sample was observed to have a crack on the line near the male slip luer.The reported complaint of a crack could be confirmed from the photos received.However, without the return of the sample a comprehensive review cannot be performed and the probable cause is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional reporter: (b)(6).Additional contact: (b)(6).

• Brand Name: 7" (18 CM) APPX 0.69 ML, EXTENSION SET, CLAVE¿ CONNECTOR
• 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: 24271042
• Report Number: 9617594-2026-00081
• Device Sequence Number: 9948183
• Product Code: FPA
• UDI-Device Identifier: 00887709037557
• UDI-Public: (01)00887709037557(17)300701(10)14511571
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: MC33257
• Device Lot Number: 14511571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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: SALINE, MFR UNK.
• Patient Sex: Unknown