MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.77 ML, SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	B1701
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved a 4" (10 cm) smallbore trifuse ext set w/2 remv check valves, 3 clamps (red, yellow, white), luer lock, non dehp tubing where the customer reported that the device was leaking below caps.The event occurred during patient use, but harm was not reported as a consequence of the vent.There was possible delay in therapy due to having to replace line/extensions.Information on specific fluid or medication is not available.There were 2 occurrences.
Additional Manufacturer Narrative
The customer provided an image showing a close up of the back check valve on the set.The complaint of leaking below caps could not be confirmed based on the returned image.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Corrected information can be found in b1 - adverse event/product problem, b2 - death date null, concomitant product and h6 health effect - impact codes.Updated information can be found in d9.A lot history review could not be conducted because a lot number was not provided or identified.

• Brand Name: 4" (10 CM) APPX 0.77 ML, SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAM
• 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: 21048197
• Report Number: 9617594-2024-01910
• Device Sequence Number: 8409275
• Product Code: FMG
• UDI-Device Identifier: 00887709068476
• UDI-Public: (01)00887709068476
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: B1701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/31/2024
• 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: UNSPECIFIED IV LINE, MFR UNK.
• Patient Sex: Unknown