MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.69 ML EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a set extension 7in w/microclave clear/clamp/rotating luer ca/50 where the customer reported that during the patient¿s medication infusion, the extension tubing came apart from the microclave.T.The patient was already infusing, and it fell apart during infusion the patient was not moving his infusion while he was hooked up to it.The reporter stated that in this instance, he (the patient) had received all of the medication and only missed the normal saline flush to clear the iv line.Once it came apart, the customer stated that they could not hook him back up with another extension as the line was now open to the air leaving potential for bacteria to enter in what should be a closed system.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for evaluation, however, a device history review should be conducted.(b)(6).

• Brand Name: 7" (18 CM) APPX 0.69 ML EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24916568
• Report Number: 9617594-2026-00385
• Device Sequence Number: 9827337
• Product Code: FPA
• UDI-Device Identifier: 00887709037236
• UDI-Public: (01)00887709037236(17)300901(10)14567070
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: MC33001
• Device Lot Number: 14567070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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
• Patient Sex: Unknown