MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.39 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATIN; STOPCOCK, I.V. SET

Model Number MC33599

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The event involved a 60" (152 cm) appx 0.39 ml, smallbore ext set w/microclave® clear, clamp, rotating luer in which the customer reported that white sediment was observed inside the luer lock connector.There was no unexpected or prolonged care, or invasive procedure as a consequence of the event.There was patient involvement and no harm reported.

Manufacturer Narrative

The complaint of particulate could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review could not be reviewed due to the unknown lot number.

Manufacturer Narrative

One used 60" (152 cm) appx 0.39 ml, smallbore ext set w/microclave® clear, clamp, rotating luer was received for evaluation on 4 may 2023.The complaint of white residuals on the microclave can be confirmed.As received there was white residuals on the female luer threads of the microclave.There were also residuals observed on inside between the body of the microclave and the seal.This type of residuals were typical of leakage during use.The probable cause of the leakage is unknown.

• Brand Name: 60" (152 CM) APPX 0.39 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATIN
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16447620
• MDR Text Key: 310354860
• Report Number: 9617594-2023-00087
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

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 Model Number: MC33599
• Device Catalogue Number: MC33599
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 03/13/2023; 05/22/2023
• Supplement Dates FDA Received: 04/10/2023; 06/14/2023
• 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