MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX. 0.36 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER L; STOPCOCK, I.V. SET

Catalog Number MC330363

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported on an unknown date, a 60" (152 cm) smallbore ext set w/microclave® clear, clamp, luer lock was found to have an issue with the bonded microclave.There is a cloudy film inside the microclave and fluid around the flat septum at the top.Additionally, it was mentioned that lipids may have exited the fluid path.There was no patient harm reported.

Manufacturer Narrative

The device was not returned for evaluation; however, a sample photo is available for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Manufacturer Narrative

The returned mc330363 assembly was confirmed with white fluid residuals typical of lipids in the female luer of the shuntless microclave.Subsequent leak testing was unable to detect any internal leakage that would have resulted in fluid ingress into the interior of the microclave.No mating devices were returned to evaluate with the shuntless microclave of the mc330363 assembly.A probable cause of the white fluid residuals in the female luer of the shuntless microclave cannot be determined.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.Additional information d9: device received 8/9/2023.Additional information g1: (b)(4).

• Brand Name: 60" (152 CM) APPX. 0.36 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER L
• 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: 17435175
• MDR Text Key: 320141590
• Report Number: 9617594-2023-00474
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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: MC330363
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: LIPIDS, UKN MFR