MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1115
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that, on an unspecified date, a 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer was found to have experienced a disconnect at the point of the filter.There was no patient harm reported.The initial reporter indicated that the event occurred twice; however, no additional information was given pertaining to the additional instances.A search of the complaint database showed no prior report of these events.
Additional Manufacturer Narrative
Additional information d9.Received two (2) used.List # b1115, 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer for inspection.The tubing on the filter outlet was disconnected on one of the samples.The bond was examined under uv light and there was no evidence of solvent present.The tubing and filter were within dimensional specifications.The complaint of filter disconnecting from tubing is confirmed on one (1) sample.The probable cause of the tubing separation is insufficient solvent applied during manual bond assembly in manufacturing.The complaint of filter disconnecting cannot be replicated or confirmed on one (1) sample.A device history lot review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
• 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: 22340974
• Report Number: 9617594-2025-01354
• Device Sequence Number: 9172287
• Product Code: FMG
• UDI-Device Identifier: 00840619045524
• UDI-Public: 00840619045524
• 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): 08/20/2025

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: B1115
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/20/2025
• 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