MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET CLAVE PORT, 2 CLAVE Y-SITES, SECURE LOCK, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	149510489
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred with regards to a primary plum set clave port, 2 clave y-sites, secure lock, 104 inch where they reported that during infusion, the cassette broke and began to leak at the tubing connection to the cassette behind the flow regulator.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Additional Manufacturer Narrative
Investigation summary received one (1) used.List #149510489, primary plum set clave port for inspection.As received, a tear in the tubing was observed on the tubing connected to the cassette outlet port.The bond was examined under uv light and was found to have sufficient solvent.No other damage or anomalies noted.Received one (1) photo of set.The set was leak tested, and leakage was observed.The reported complaint of broken cassette and leakage can be confirmed.The probable cause is due to an unintentional pulling force during use.A device history record review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PRIMARY PLUM SET CLAVE PORT, 2 CLAVE Y-SITES, SECURE LOCK, 104 INCH
• 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: 22814467
• Report Number: 9615050-2025-00390
• Device Sequence Number: 15629119
• Product Code: FPA
• UDI-Device Identifier: 10887787003205
• UDI-Public: 10887787003205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 149510489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INFUSION UNKNOWN.
• Patient Sex: Unknown