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	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer was found to have generated a leak during patient use.It was reported that the patient was set up with an intravenous (iv) and smallbore pressure infusion extension set.At the time of the injection, the extension set started to leak at the connection end.There was unspecified unexpected or prolonged care.There was no patient harm reported.
Additional Manufacturer Narrative
Received one (1) used list# mc33150, 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer; lot# unknown.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample showed evidence of an internal leak upon arrival, however, during testing the leak was unable to be replicated.The probable cause of the leak is unknown.The possible lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21860967
• Report Number: 9617594-2025-00792
• Device Sequence Number: 20013640
• Product Code: FPA
• UDI-Device Identifier: 00887709037441
• UDI-Public: 00887709037441
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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