MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" (183 CM) APPX 1.7 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2; STOPCOCK, I.V. SET

Catalog Number	MC330217
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 72" (183 cm) appx 1.7 ml, pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock where it was reported total parenteral nutrition (tpn) splitter syringe leaking on outside of tubing.Changed the tubing out and leaking continued.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as (lot number/serial number) is unknown.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: sample #1.One used list #mc330217, 72" (183 cm) appx 1.7 ml, pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock; lot #unknown.---> one used list #unknown, 30ml syringe; lot #unknown.There was evidence of a leak at connection of the microclave and syringe.No visual damages or anomalies were observed on the icu medical device.Sample #2.One used.List #mc330217, 72" (183 cm) appx 1.7 ml, pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock; lot #unknown.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed; however not from the icu medical complaint device.A leak was observed at the connection of the microclave and the syringe.It was found that the syringe had a crack on the male luer.The probable cause of the leak is from a cracked syringe.The probable cause of the crack cannot be determined on a non-icu medical product.A dhr lot # review could not be conducted because no lot number was provided or identified.Corrected information can be found in h6 component codes.

• Brand Name: 72" (183 CM) APPX 1.7 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2
• 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: 21170927
• Report Number: 9617594-2025-00124
• Device Sequence Number: 4252101
• Product Code: FMG
• UDI-Device Identifier: 00887709080638
• UDI-Public: 00887709080638
• 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,Followup
• Report Date (Section B): 03/10/2025

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: MC330217
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/10/2025
• 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: TOTAL PARENTERAL NUTRITION SPLITTER SYRING UNK MFR.
• Patient Sex: Unknown