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 Codes	Fluid/Blood Leak (1250); 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
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.E1 reporter facility name: (b)(6) hospital.
Event or Problem Description
The event occurred on an unspecified date and involved a 8" (20cm) appx 0.48ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer where it was reported that the filter had occlusion issues or leaking.Icu med-portfolio sales specialist confirmed that they are using them within the manufacturer's recommendations.There was unknown patient involvement and unknown human harm.
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.
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 1 of 4 devices.

• 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: 17775617
• Report Number: 9617594-2023-00731
• Device Sequence Number: 6252616
• 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,Followup
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement 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