MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP,; STOPCOCK, I.V. SET

Catalog Number	MC33932
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D1.Device name: 60" (152 cm) appx 1.0 ml, smallbore ext set w/microclave® clear, clamp, luer lock without a lot number the expiration and manufacturing dates are unknown.Investigation summary no product samples, pictures, or videos were received for investigation.The complaint of a tubing connection from microbore tubing to pall filter was leaking 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 was identified.
Event or Problem Description
An event involving a 60" (152 cm) appx 1.0 ml, smallbore ext set w/microclave® clear, clamp, luer lock experienced leakage.It was reported that this was an incident for item bopmc33932 icu medical microbore tubing and item ime10011865 bd pal filter when used together.Upon tracing tubing for dual sign nicardipine rate change, noticed that tubing connection from microbore tubing to pall filter was leaking.Tubing was changed and saq was notified.The mating device is a bd pal filter with list number 10011865 and lot number (10)24029420.The event happened on 19-may-2024.Sample is available for return.There was patient involvement and no patient harm.

• Brand Name: 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP,
• 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: 19997459
• Report Number: 9617594-2024-01146
• Device Sequence Number: 11852936
• Product Code: FMG
• UDI-Device Identifier: 00887709072503
• UDI-Public: 00887709072503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/15/2024

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: MC33932
• 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: 07/01/2024
• Initial Report FDA Received Date: 08/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IME10011865 PAL FILTER, BD
• Patient Sex: Unknown