MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142560488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a primary plum set, 0.2 micron filter, prepierced y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 104 inch where it was stated in the report that chemotherapy (keytruda+cisplatin+etoposide) was administered from 21 april to 23 april.On 23 april, after completion of chemotherapy, leakage from the filter was found.There was no patient harm reported.

• Brand Name: PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT
• 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: 25216962
• Report Number: 9615050-2026-00294
• Device Sequence Number: 9998004
• Product Code: FPA
• UDI-Device Identifier: 10887787005230
• UDI-Public: (01)10887787005230(17)280401(10)14338116
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 142560488
• Device Lot Number: 14338116
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/19/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CISPLATIN, MFR UNKNOWN; ETOPOSIDE, MFR UNKNOWN; KEYTRUDA, MFR UNKNOWN
• Patient Sex: Unknown