MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC330523
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) used.List #mc330523 was received for evaluation.As received an internal dry amino acids/dextrose residual was observed on the 0.2-micron filter, no additional damage or anomalies were observed.The set was primed through the 0.2-micron filter, and the internal dry residual was cleaned after the test, a leak from one of the filter vents was observed.A device history review (dhr) review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
It was reported that a 127" (323 cm) appx 9.7 ml, transfer set w/microclave® clear, dual check valve, smallbore clear/pur yellow trifuse ext set w/2 microclave® clear (yellow, green rings), 2-0.2 micron filters, rotating luer generated a leak during testing to the returned device.As per the initial report the trifuse extension set was noted to have moisture/sticky fluids on the green ring lumen 0.2 micron filter.Lumen was infusing amino acids/dextrose solution.There was no patient harm.

• Brand Name: 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: 19613625
• Report Number: 9617594-2024-00821
• Device Sequence Number: 6140910
• Product Code: FMG
• UDI-Device Identifier: 00887709092020
• UDI-Public: (01)00887709092020
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: MC330523
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 06/26/2024
• 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: AMINO ACIDS/DEXTROSE SOLUTION, UNK MFR
• Patient Sex: Unknown