MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, PREPIERCED Y-SITE, SECURE LOCK, 80 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126720490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.No product samples, pictures, or videos were received for investigation.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
A primary set, prepierced y-site, secure lock, 80 inch reportedly leaked four drops of chemotherapy (doxorubicin) from the y-site less than 10 minutes into a 30-minute infusion.The four drops leaked onto the floor.The port was not pierced at the time, the product was used in conjunction with closed system transfer devices (cstds).The staff cleaned the spills which consisted of four droplets on the floor.This was used on a veterinary patient.There was no injury to patient or health professional.

• Brand Name: PRIMARY SET, PREPIERCED Y-SITE, SECURE LOCK, 80 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: 25279297
• Report Number: 9615050-2026-00307
• Device Sequence Number: 10059605
• Product Code: FPA
• UDI-Device Identifier: 10887787006022
• UDI-Public: (01)10887787006022(17)280201(10)14271623
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K142367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 126720490
• Device Lot Number: 14271623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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: CHEMOTHERAPY (DOXORUBICIN), MFR UNK; UNSPECIFIED CSTD MATING DEVICES, MFR UNK
• Patient Sex: Unknown