MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHECK VALVES, 0.2 MICRON F; STOPCOCK, I.V. SET

Catalog Number	MC33547
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An event occurred on an unknown date 6" smallbore trifuse ext set w/3 microclave® clear, 2 check valves, 0.2 micron filter, 3 clamps (white, blue, yellow), rotating luer experienced leakage.The report stated that it is faulty and leaking filters.There was unknown patient involvement and unknown harm.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown.(b)(6) 2024 has been used as a place holder.D9 - date returned to mfg - 18 jul 2024.
Additional Manufacturer Narrative
Eleven new list #mc33547, 6" were returned for evaluation.As received, there was no physical damage or anomalies, no mating device was returned for evaluation.All the returned sets were primed and there were no leaks from the 0.2 micron filter vent or any other location.The customer's complaint of leaks cannot be confirmed based on the physical sample evaluation.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHECK VALVES, 0.2 MICRON F
• 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: 19914525
• Report Number: 9617594-2024-01075
• Device Sequence Number: 18166429
• Product Code: FMG
• UDI-Device Identifier: 00887709057807
• UDI-Public: (01)00887709057807(17)290301(10)13921491
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: MC33547
• Device Lot Number: 13921491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: UNSPECIFIED DRUG , MFR UNK.
• Patient Sex: Unknown