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	Disconnection (1171)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
An email was received regarding a 7" (18 cm) appx 0.69 ml ext set w/microclave clear, clamp, rotating luer in which it was reported that the patient peripheral iv line connected to alaris pump and infusing medication disonnecter during use and lead to blood loss.The patient was witnessed by writer raising his arm, line was clear of obstacles and secured to patient, with no tightness in infusion line.Luer lock connection at the tip of extension became disconnected from the rest of the line but remained connected to infusion line.This left a partial extension tubing open to the environment and patient began to drain blood through partial extension connected to iv line.Writer applied green kelly clamp over remaining portion of extension to stop bleeding and replaced the extension with a new unit without further complication.The patient lost less than 5cc of blood as this event was witnessed with prompt response.The procedure done was intravenous access and there was an unexpected, prolonged care.There was a patient involvement but no harm.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25153155
• Report Number: 9617594-2026-00447
• Device Sequence Number: 9351440
• Product Code: FPA
• UDI-Device Identifier: 00887709037236
• UDI-Public: (01)00887709037236(17)301201(10)14762707
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 14762707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIGOXIN MIXED IN SALINE, BAXTER
• Patient Sex: Male