MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE® STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON; STOPCOCK, I.V. SET

Catalog Number	SC121
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The event occurred on an unspecified date and involved a 60" smallbore trifuse ext set w/4-way clave® stopcock, 2 microclave®, 0.2 micron filter, rotating luer where it was reported that filter was defected on total parenteral nutrition line, there are two small circles on filter and one of the circles was found to be leaking.There was no report of patient harm.
Additional Manufacturer Narrative
One (1) used sample list sc121 was returned for evaluation.As received, a dry infusate solution and wetted out condition on the inlet filter 0.2 micron was observed.No additional damage or anomalies were observed.The set was primed as per procedure and a leaks coming the inlet filter vents was confirmed.No additional leaks, along the device were observed.Complaint of leaks can be confirmed.The probable cause is typical due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE® STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON
• 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: 17824575
• Report Number: 9617594-2023-00754
• Device Sequence Number: 11382918
• Product Code: FMG
• UDI-Device Identifier: 00887709040106
• UDI-Public: (01)00887709040106(17)280301(10)13575419
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/06/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: SC121
• Device Lot Number: 13575419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: TOTAL PARENTERAL NUTRITION, MFR UNK.
• Patient Sex: Unknown