MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 I; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126620490
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.The complaint could not be replicated or confirmed, as no product was returned for evaluation.
Event or Problem Description
An event occurred on an unspecified date involving a primary set, piggyback with backcheck valve, 2 clave y-sites, secure lock, 100 inch, reporting that mobile and immobile debris was observed floating in the drip chamber of the iv tubing after spiking a normal saline bag.The bag and tubing were sequestered, and the supply chain was notified.The contaminant is suspected to have originated from the iv tubing.The affected lot was removed from use in the ed.In most cases, a single brown or black spot was observed in the same area of the drip chamber.It was noted that in some instances the speck appeared black, while in others it appeared brown.In both cases, the specimen appeared to be embedded in the plastic of the drip chamber in nearly identical locations.The drip chamber was opened to allow access to the speck.Attempts were made to remove the speck; however, it could not be removed.Even with aggressive scraping using a scalpel, the speck remained embedded in the inner plastic surface of the drip chamber.There was no reported patient involvement and no reported patient harm.

• Brand Name: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 I
• 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: 25436367
• Report Number: 9615050-2026-00418
• Device Sequence Number: 13296161
• Product Code: FPA
• UDI-Device Identifier: 10887787005643
• UDI-Public: (01)10887787005643(17)290101(10)14822772
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 126620490
• Device Lot Number: 14822772
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2026
• 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