MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	B1434
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint involved a 8" (20 cm) appx 0.49 ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer.It was reported that the filter noted to be leaking at 2 points on the back of filter.The status of the product at the time of the event was use on patient.There was patient involvement, no adverse event but there was delay in therapy.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Received one used device for evaluation; no visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample was found to have a leak on the in-line filter.The probable cause is from the temporary loss of hydrophobic properties during use.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22299722
• Report Number: 9617594-2025-01307
• Device Sequence Number: 21267188
• Product Code: FMG
• UDI-Device Identifier: 00887709001657
• UDI-Public: 00887709001657
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: B1434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/28/2025
• 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
• Patient Sex: Unknown