MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK; STOPCOCK, I.V. SET

Catalog Number	B55005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 14" ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext where it was reported intravenous (iv) infusions attached to manifold was leaking fluid from buttons of the manifold.Interruption of continuous iv medications could potentially affect patient¿s heart rate, blood pressure, pain management, and sedation levels.The caregiver changed out leaking manifolds to address the issue.The product was used on a patient at the time of the incident.No patient harm or serious deterioration in the state of health of the patient.There was a delay in critical therapy when the problem was noted as patient was not receiving full dose of iv meds.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.Additional contact: (b)(6).
Additional Manufacturer Narrative
Received two (2) used b55005 ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red) for inspection.No defects or anomalies were noted.Each valve was connected to a 36" head height fluid reservoir from the side port, primed, and left for 24 hours.There was leakage from the green port button on both samples.The reported complaint can be confirmed.The probable cause is related to a molding defect in the white button molded component used in the 1o2 smart valve.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 8/1/2024.

• Brand Name: 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK
• 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: 19816322
• Report Number: 9617594-2024-00929
• Device Sequence Number: 21055554
• Product Code: FMG
• UDI-Device Identifier: 00887709010079
• UDI-Public: (01)00887709010079(17)281001(10)13800585
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: B55005
• Device Lot Number: 13800585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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 MEDICATION, UNK MFR
• Patient Sex: Unknown