MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33326
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is unknown.A supplemental mdr will be submitted if any updates become available.
Event or Problem Description
An event occurred on an unspecified date involving a 7" (18 cm) appx 0.43 ml, pressure infusion (400psig) ext set w/remv microclave® clear, rotating luer stated that the iv (intra-venous line) separated resulting in a significant amount of blood loss.20 gauge inserted to ac (antecubital fossa), extension set attached fluid hung and was running fine when nurse left the procedure room.Anesthesia entered the room minutes later and patient stated she was bleeding.The patient lost a significant amount of blood, but patient denied having any symptoms.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
Investigation summary: the complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history was reviewed, and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®
• 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: 23861403
• Report Number: 9617594-2025-02323
• Device Sequence Number: 15954077
• Product Code: FPA
• UDI-Device Identifier: 00887709037755
• UDI-Public: (01)00887709037755(17)300801(10)14525673
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: MC33326
• Device Lot Number: 14525673
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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: UNSPECIFIED ANESTHESIA, UNK MFR.
• Patient Sex: Unknown