MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LU; STOPCOCK, I.V. SET

Catalog Number	Z0792
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned 4 used devices for investigation.Fluid flow occlusions were confirmed in all four of the returned used z0792 extension set assemblies, however, no leakage was observed.This captures 3 of 4 devices.
Additional Manufacturer Narrative
Received one used.List #z0792, 8" (20cm) appx 0.48ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer; lot #9285958.Fluid flow occlusion was confirmed in the returned used z0792 extension set assembly; however, no leakage was observed.The probable cause of the occluded flow is a filter clog.The dfu states: a filter that clogs during infusion should be replaced.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LU
• 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: 18050488
• Report Number: 9617594-2023-00913
• Device Sequence Number: 12628892
• Product Code: FMG
• UDI-Device Identifier: 00887709021822
• UDI-Public: (01)00887709021822(17)270901(10)9285958
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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: Z0792
• Device Lot Number: 9285958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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