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 (BLUE), L; STOPCOCK, I.V. SET

Catalog Number	MC330425
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date in march 2024 and involved a 60" (152 cm) appx 1.0 ml, smallbore ext set w/microclave¿ clear, clamp (blue), luer lock.It was reported via medwatch ((b)(4)) on 31-jul, which stated that when flush was hung after synthroid was given, this rn (registered nurse) noticed that the medication at the hub (near the iv pump) was leaking.Tubing was then replaced, no harm noted.There was patient involvement and no patient or staff harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Pending device history records.
Additional Manufacturer Narrative
The complaint on the mc330425 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Lot history review was performed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, CLAMP (BLUE), L
• 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: 20072746
• Report Number: 9617594-2024-01201
• Device Sequence Number: 3075454
• Product Code: FMG
• UDI-Device Identifier: 00887709088191
• UDI-Public: (01)00887709088191(17)290101(10)13867325
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/04/2024

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: MC330425
• Device Lot Number: 13867325
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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: UNSPECIFIED MEDICATION, UNKNOWN MFR
• Patient Sex: Unknown