MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. Y-TYPE MICROBORE EXTENSION SET - 8 INCH, 2 REMOVABLE CLAVE CONNECTORS, SPIN COLL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	206550480
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
An event involving y-type microbore extension set - 8 inch, 2 removable clave connectors, spin collar reported that they have siting a leak at the hub and backflow in the tubing.There were patient involvement and no patient harm reported.
Additional Manufacturer Narrative
D9 - date returned to mfr: 3/10/2026.Received one (1) used.List #206550480, y-type microbore extension set - 8 inch, 2 removable clave connectors, spin collar for inspection.As received, there was a stickdown on one (1) clave.The set was leak tested per specification and leakage was observed.The clave with a stickdown was disassembled and a bent spike and torn seal were observed.The reported complaint of leak and backflow can be confirmed.The probable cause of the bent spike is unknown and cannot be determined without the return of the used mating device.This complaint is being escalated to an ongoing corrective and preventative action (capa) investigation to further evaluate root cause, assess historical production risk, and implement appropriate corrective actions.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: Y-TYPE MICROBORE EXTENSION SET - 8 INCH, 2 REMOVABLE CLAVE CONNECTORS, SPIN COLL
• 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: 24543241
• Report Number: 9615050-2026-00163
• Device Sequence Number: 14846011
• Product Code: FPA
• UDI-Device Identifier: 10887787005865
• UDI-Public: (01)10887787005865(17)280901(10)14483283
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 206550480
• Device Lot Number: 14483283
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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
• Patient Sex: Unknown