MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142540489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of leakage and stick down could not be confirmed by the investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot history review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
It was reported via a medsun mandatory medwatch report that on, an unspecified date in (b)(6), a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch generated a leak during patient use.The b-port on the primary tubing connected to a chemolock was found to be leaking once the secondary line was running with the fluorouracil.The infusion was stopped, tried retightening the connection, disconnected, and reconnected the chemolock.The medication continued to leak from under the cl2100 device.The b-port hub stayed depressed when the connection was removed.The original intended procedure was chemotherapy infusion.Set, administration, intravascular.This is not a single-use device that was reprocessed and reused on a patient.This device is available for evaluation.This type of report is a product problem.This type of reportable event is a malfunction.This is an initial type of report.This report was sent to manufacturer.The initial reporter is (b)(6).A biomedical engineer and health professional from memorial care.The contact person is (b)(6) from (b)(6) medical center.The location where the event occurred was at the hospital and patient room.Pgiron 18-sep-2024.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• 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: 20457041
• Report Number: 9615050-2024-00759
• Device Sequence Number: 8830825
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: 10887787006039
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 142540489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 02/10/2025
• 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