MAUDE Adverse Event Report: ICU Medical Costa Rica Ltd. Primary PLUMSET, PE Lined Tubing, 107 Inch; set, administration, intravascular

Catalog Number	142480489
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involving a primary plumset, pe lined tubing, 107.It was reported that the drip could not be locked and continued to flow.There was patient involvement; however, no patient harm was reported.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).One photo of the set in a bag was received for evaluation.The photo had been edited by the customer to place a red box around the cassette on the set.Review of the provided photo found no evidence of unrestricted flow.The used set was not returned for evaluation; therefore, the reported condition could not be replicated or confirmed.A device history review could not be completed due to the unknown lot number.

• Brand Name: Primary PLUMSET, PE Lined Tubing, 107 Inch
• Common Device Name: set, administration, intravascular
• Manufacturer (Section D): ICU Medical Costa Rica Ltd.; zona franca global; la aurora heredia NA ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50805951
• Report Number: 9615050-2026-01319
• Device Sequence Number: 15589265
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 142480489
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/17/2026
• 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