MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY MICRODRIP 150 ML BURETTE SET WITH FLOAT VALVE, CLAVE ADDITIVE PORT, 15 M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	19208-01
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
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 primary microdrip 150 ml burette set with float valve, clave additive port, 15 micron filter in sight chamber, clave y-site, secure lock, 198 cm, became occluded during patient use.It was stated in the report, ¿no flow from insertion point.¿ it occurred during use on a patient; no specific time was given.The issue was identified when a staff nurse noticed an absence of intravenous (iv) fluid movement.The data was communicated during the reporter¿s visit to the account.One unit was affected, and the sample is available for retrieval and evaluation.The product is not contaminated and does not contain any biohazards or chemotherapeutic agents.The event involved a patient and caused a delay in therapy, but no adverse event or harm was reported.
Additional Manufacturer Narrative
Received one (1) used.List #19208-01, primary microdrip 150 ml burette set with float valve for inspection.No damage or anomalies noted.A particulate residual was observed in the fluid pathway.The complaint of no flow can be confirmed.The probable cause is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY MICRODRIP 150 ML BURETTE SET WITH FLOAT VALVE, CLAVE ADDITIVE PORT, 15 M
• 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: 22573507
• Report Number: 9615050-2025-00354
• Device Sequence Number: 11690822
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K142622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 19208-01
• Device Lot Number: 13935491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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