MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 132" (335 CM) 60 DROP 150 ML BURETTE SET (W/SHUT-OFF), PRE-PIERCED PORT, 4-WAY S; STOPCOCK, I.V. SET

Catalog Number	Z2890
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo and video of the affected sample was received from the customer.The photo showed the packaging of the affected sample.The video showed some material in the fluid of the burette.The reported complaint of material in the sample could be confirmed from the video provided.However, without the return of the used sample, a comprehensive review cannot be performed and the probable cause is unknown.The lot history was reviewed.No nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The following medical device: 132" (335 cm) 60 drop 150 ml burette set (w/shut-off), pre-pierced port, 4-way stopcock, clave¿, rotating luer, 1 ext, 1 drop-in microclave¿ ext set.The customer reported white particle/material floating inside the buretrol while preparing for his cases that day.He primed the set with a 500ml 0.9% normal saline bag in order to show the white particulate in a customer-provided video for complaint investigation.There was no patient involved in this reported event.

• Brand Name: 132" (335 CM) 60 DROP 150 ML BURETTE SET (W/SHUT-OFF), PRE-PIERCED PORT, 4-WAY S
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24249154
• Report Number: 9617594-2026-00060
• Device Sequence Number: 20933345
• Product Code: FMG
• UDI-Device Identifier: 00887709028456
• UDI-Public: (01)00887709028456(17)300701(10)14482283
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: Z2890
• Device Lot Number: 14482283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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