MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33150
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation however a device history review should be performed.Additional contact information (b)(6).
Event or Problem Description
An event involving a 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer reported that on two separate occasions within less than one week, after the extension set was connected to a patient¿s intravenous (iv) line and a flush was completed and disconnected, the patient¿s blood rapidly refluxed into the tubing and then flowed out through the microclave connector onto the floor.It was also mentioned that the connector was accessed once at the time the iv was placed (saline).The connector was accessed with a 20g viavalve needle (smith medical jelco) and 10ml preloaded saline flush (bd posiflush sp).There was patient involvement and no harm/adverse event reported.The event occurred on two different dates, and this report captures second of two incidents.
Additional Manufacturer Narrative
Addition information: h10 - related report numbers - added related record.Investigation summary: complaint of backflow of fluid / bleedback on item mc33150 cannot be confirmed.Since 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 probable cause cannot be determined.

• Brand Name: 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV
• 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: 24451364
• Report Number: 9617594-2026-00197
• Device Sequence Number: 9968606
• Product Code: FPA
• UDI-Device Identifier: 00887709037441
• UDI-Public: (01)00887709037441(17)301101(10)14776269
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: MC33150
• Device Lot Number: 14776269
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2025
• 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: 10ML PRELOADED SALINE FLUSH (BD POSIFLUSH SP).; 20G VIAVALVE NEEDLE (SMITH MEDICAL JELCO).
• Patient Sex: Unknown