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

Device Problems Fluid/Blood Leak (1250); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.E1 reporter facility name: (b)(6) hospital.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 323756041
• Report Number: 9617594-2023-00731
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1