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	02/09/2025
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 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer where the customer reported that the patient was being held by the mother, and she felt wetness while holding patient.When both parents looked for the source of the wetness, they found the lipid filter has disconnected/separated.There was patient involvement but there was no harm as a consequence of this event.There was a delay in therapy as filter tubing had to be changed out.
Additional Manufacturer Narrative
D9.Product received date: 3/26/2025.Investigation summary received one (1) used b1115 ext set w/ 1.2 micron filter for inspection.The tubing was separated from the outlet port on the 1.2 micron filter.There was little to no solvent present on the tubing or outlet port.The inlet bond was tested for bond integrity per product specifications.The representative bond met performance expectations.The reported complaint can be confirmed.The probable cause is due to insufficient solvent applied during manual assembly in ensenada.A device history record lot# review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
One used device was returned for evaluation.The tubing was separated from the outlet port on the 1.2 micron filter.There was little to no solvent present on the tubing or outlet port.The inlet bond was tested for bond integrity per product specifications.The representative bond met performance expectations.The reported complaint can be confirmed.The probable cause is due to insufficient solvent applied during manual assembly in manufacturing.Lot history 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: 21677826
• Report Number: 9617594-2025-00540
• Device Sequence Number: 7600312
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2025

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: UNKNOWN
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 06/03/2024
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/27/2025; 10/09/2025
• 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