MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 117" (297 CM) 60 DROP 50 ML BURETTE SET, SHUT-OFF, CHECK VALVE, 2 MICROCLAVE®, R; STOPCOCK, I.V. SET

Catalog Number	B99172
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a 117¿ (297 cm) 60 drop 150 ml burette set (clave¿, shut-off) w/2 clave¿, rotating luer with list number b99172 and lot number 14065212.It was stated in the report that earlier this week, during the first 100 cc of fluid administration to the baby, the blue ring floated as expected.Once the first 100 cc was given to the patient, the anesthesiologist started to refill the chamber.Once the chamber was refilled, they observed that the intravenous (iv) was not flowing.While troubleshooting that problem, he noticed that the blue ring was stuck to the bottom of the bureterol chamber, and despite their efforts, the blue ring would not float back up and was stuck to the base of the chamber.That would not allow the fluid to flow forward.They had to take the said bureterol set out of the system, and used a second bureterol, which worked as expected.The fluid was a lactated ringer's with part number 07953-09, and there was no drug quality issue with the lactated ringer's.The sample is available for evaluation.There was no patient harm, but there was a couple of minutes' delay in therapy.
Additional Manufacturer Narrative
The device was received for evaluation, and no visual damages or anomalies were observed.The blue ring was floating upon arrival.The reported complaint of the blue ring being stuck could be confirmed from the received photo.However, the blue ring was floating upon arrival and met product specifications.The probable cause of the blue ring being stuck is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 117" (297 CM) 60 DROP 50 ML BURETTE SET, SHUT-OFF, CHECK VALVE, 2 MICROCLAVE®, R
• 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: 22906306
• Report Number: 9617594-2025-01758
• Device Sequence Number: 18414389
• Product Code: FMG
• UDI-Device Identifier: 00887709019225
• UDI-Public: (01)00887709019225(17)290701(10)14065212
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: B99172
• Device Lot Number: 14065212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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