MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	146870489
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch which was reported that they had multiple contaminated primary plum sets - one set had been spiked to a zosyn bag but was caught prior to patient use.Some are small to large brown spots.In total, 66 were identified as contaminated.There was visible contamination in the drip chamber.As a result, they set aside all of their sets with the same lot number.Sample photos were attached.
Additional Manufacturer Narrative
Evaluation of the returned sets confirmed the presence of black spots and white discoloration adhered to the interior wall of the drip chamber.Measurement of the black spots identified one (1) set as out of specification.Measurement of the white discoloration identified three (3) sets as out of specification.Measurement of the white discoloration and black specks together identified one (1) set as out of specification.The adhered spots observed during evaluation were confirmed to be embedded within the drip chamber.Icu medical has completed its investigation and determined that these represent discolored material originating during the molding process and embedded within the drip chamber wall.These findings are not consistent with foreign or biological contamination, and testing demonstrates that the material does not dislodge or migrate.The reported complaint of spots can be confirmed.The cause of the black spots in the drip chamber is due to discoloration of the pvc material during the molding process.The cause of the white discoloration inside the drip chamber is due to errant solvent applied during the assembly process in costa rica.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 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: 25585643
• Report Number: 9615050-2026-00636
• Device Sequence Number: 17542338
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)281001(10)14625446
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: 146870489
• Device Lot Number: 14625446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown