MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18 CM (7") APPX 0.56 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO; STOPCOCK, I.V. SET

Catalog Number	011-C3323
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The incident involved a 18 cm (7") appx 0.56 ml, smallbore trifuse ext set w/3 microclave®, 3 clamps, rotating luer on an unknown date.The customer reported that the set was leaking infusion product from one of the extender valves.The valve was damaged at the end; the rubber which seals it was missing.There was unknown patient involvement and unknown harm.

• Brand Name: 18 CM (7") APPX 0.56 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO
• 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: 18013062
• Report Number: 9617594-2023-00884
• Device Sequence Number: 12632047
• Product Code: FMG
• UDI-Device Identifier: 00840619001773
• UDI-Public: (01)00840619001773(17)250701(10)4922392
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/18/2023

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 Expiration Date: 07/01/2025
• Device Catalogue Number: 011-C3323
• Device Lot Number: 4922392
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• 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
• Patient Sex: Unknown