MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.71 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 0.2 MI; STOPCOCK, I.V. SET

Catalog Number	MC33587
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 involved a 6" (15 cm) appx 0.71 ml, smallbore trifuse ext set w/3 microclave¿ clear, 0.2 micron filter, 3 clamps (blue, yellow, white), rotating luer experienced leakage.The report stated that faulty and leaking filters.There was unknown patient involvement and unknown harm.
Additional Manufacturer Narrative
B3 date of event is unknown, 1 jul 2024 has been used as a place holder d4.And h4.Because lot number is unknown, the expiration and manufacture dates are unknown.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Received four used mc33587 smallbore trifuse ext sets and three new mc33587 for inspection on 7/18/24.Each of the filter vents on the used sets was wetted out with prior infusate.Each set was leak tested per product specifications.There was leakage on three out of the four used sets from the filter vents.There was no leakage on the new samples.The reported complaint of leakage can be confirmed on three of the used sets.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The possible lot numbers history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6" (15 CM) APPX 0.71 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 0.2 MI
• 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: 20027975
• Report Number: 9617594-2024-01168
• Device Sequence Number: 7448653
• Product Code: FMG
• UDI-Device Identifier: 00887709057906
• UDI-Public: 00887709057906
• 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
• 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): 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: MC33587
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/10/2024
• 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
• Patient Sex: Unknown