MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33131
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An event involving a 7" (18 cm) appx 0.43 ml, pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer experienced separation.The report stated that there was a recent disconnection with the mc33131 while under pressure.There was no patient harm, the set was reconnected, and the procedure was successfully completed.It is possible that the connection was not tight.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The lot number is unknown, resulting in unknown expiration and manufacturing dates.Investigation summary: 7/24/2024.No product samples, pictures, or videos were received for investigation.The complaint of disconnection while under pressure could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 19955237
• Report Number: 9617594-2024-01117
• Device Sequence Number: 18366999
• Product Code: FPA
• UDI-Device Identifier: 00887709037434
• UDI-Public: 00887709037434
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• 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): 08/09/2024

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: MC33131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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