MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC9013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of leakage on the mc9013 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 review (dhr) for possible lot 13870091 was reviewed, and no non-conformities were found that would have led to the reported complaint.
Event or Problem Description
It was reported that a 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer generated a leak during patient use.The report states that they were infusing paclitaxel when they noticed a leak.It was also reported that the dose was a 24-hour infusion of paclitaxel, with a concentration around 0.8mg/ml.It appeared that the leaking occurred later on during the infusion, according to patient accounts.Additionally, it was reported that the dose started at (b)(6) 2024, 18:33.On (b)(6) 2024, about 4 pm, the patient was sitting in the chair on their computer and noticed a wet stain on their gown.The filter was leaking from a divot.The nurses came to replace and clean the area.There was patient involvement and no reported harm.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24323168
• Report Number: 9615050-2026-00075
• Device Sequence Number: 9475942
• Product Code: FPA
• UDI-Device Identifier: 00887709039391
• UDI-Public: 00887709039391
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: MC9013
• 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: 03/12/2024
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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