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
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 clave¿, 0.2 micron filter, rotating luer.It was reported that the filters leaked total parenteral nutrition (tpn) and required multiple changes.The event occurred while the product was in use with a patient but there was no human harm; the customer stated that the nurses stayed on top of this issue so their patients did not suffer an infection or hypoglycemia.This report is one of three.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
The device is not returned for evaluation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.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: 17899301
• Report Number: 9617594-2023-00813
• Device Sequence Number: 14316186
• Product Code: FMG
• UDI-Device Identifier: 00887709040106
• UDI-Public: (01)00887709040106(17)271101(10)12733852
• 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,Followup
• Report Date (Section B): 09/13/2023

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: 12733852
• Was Device Available for Evaluation?: No
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 10/26/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/21/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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