MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 I; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126640489
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.A lot number has been provided, a device history lot review is pending.Additional reporter: (b)(6).
Event or Problem Description
The event involved a primary set, piggyback with backcheck valve, 3 clave y-sites, secure lock, 100 inch.It was reported the patient arrived to or with iv fluid running.During intubation, iv tubing was found to be defective as iv meds were backflowing out of the proximal iv port.Anesthesia realized after giving rocuronium and propofol.Unsure how much medication pt received due to meds coming out of proximal port.Writer informed prep room nurse of iv malfunction.The product was used for two weeks before the problem occurred.The problem was discovered by an or rn.The device was re-sterilized or re-processed.There was patient involvement and no adverse event.They have two documented cases that both have the same exact issue.This report captures 2 occurrences.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of backflow could not be confirmed by the investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 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: 21193259
• Report Number: 9615050-2025-00042
• Device Sequence Number: 17023605
• Product Code: FPA
• UDI-Device Identifier: 10887787005964
• UDI-Public: (01)10887787005964(17)270701(10)14017985
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 126640489
• Device Lot Number: 14017985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROPOFOL, UNK MFR; ROCURONIUM, UNK MFR
• Patient Sex: Unknown