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	02/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation- it has been requested.The investigation is pending.
Event or Problem Description
The event occurred on an unknown date involving a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch.It was reported that the device was leaking at the filter on the total parenteral nutrition (tpn) tubing.No reported patient involvement and harm.The patient involvement is unknown and the patient harm is unknown.
Additional Manufacturer Narrative
The following fields were updated with additional information/correction due to information received form the customer: b3: date of event, b5: describe event or problem, d4: lot #, expiration date, primary udi number, d9: device available for evaluation, h4: device manufacture date.
Event or Problem Description
Need a supplemental for the update received."lot# 14576672.There was patient involvement and no harm.Event date was (b)(6) 2026.Status was during infusion.".
Event or Problem Description
The event occurred on an unknown date involving a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch.It was reported that the device was leaking at the filter on the total parenteral nutrition (tpn) tubing.No reported patient involvement and harm.There was patient involvement and no harm.
Additional Manufacturer Narrative
One used primary plum set was returned for evaluation.Unknown solution residue was observed on the returned device.Visual inspection identified a small puncture in the tubing connected to the inline filter.Functional leak testing was performed, and leakage was observed from the punctured tubing.The reported allegation of tubing leakage was confirmed.The manufacturing process was reviewed, and no sharp objects or instruments capable of causing the observed damage were identified on the manufacturing floor.The probable cause of the puncture could not be determined.B5 - updated.D9 - date returned to mfr : 4/10/2026.

• 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: 24564958
• Report Number: 9615050-2026-00172
• Device Sequence Number: 9330950
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2026

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: 142540489
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 07/29/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/02/2026; 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2025
• 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: TOTAL PARENTERAL NUTRITION (TPN) TUBING, MFR UNK.
• Patient Sex: Unknown