MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	123390488
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum set, orange polyethylene lined light resistant tubing, clave y-site, secure lock, 103 inches where it was reported that the clave cracked.The patient involvement was unknown, but no patient harm reported.
Additional Manufacturer Narrative
One (1) used.List #123390488, primary plum set returned for evaluation.As received, the y-site housing had a crack with a white particle inside the crack.No other damage or anomalies were observed.The reported complaint of clave crack can be confirmed.The probable cause is low viscosity plastic resin in combination with a small inclusion during molding in manufacturing.This failure mode is a known defect covered in icu medical risk documents and can happen at low frequency.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE
• 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: 23295223
• Report Number: 9615050-2025-00476
• Device Sequence Number: 10027609
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)271101(10)14132134
• Combination Product (Y/N): N
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 123390488
• Device Lot Number: 14132134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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