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	12/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
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 the manifold was leaking at propofol site for a patient under sedation (sedation for antiepileptic reasons).Before the reported issue, the patient was sedated and intubated due to post code blue.Patient had severe myoclonic seizures and was kept stable with sedation.During the reported issue, the patient was stable with sedation.After the reported issue, the patient was stable as the nurse noticed prior to any seizures resuming.The patient was not harmed; however, it was considered near miss - high risk.The delay in therapy was the patient not receiving the propofol needed to control her epileptic events.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
Investigation summary: received one (1) used list# b55005 manifold w/ baseplate.As received, no defects or anomalies were observed.The set was leak tested per product specifications.No leakage was observed.The complaint of "manifold leaking at propofol site" could not be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21256721
• Report Number: 9617594-2025-00201
• Device Sequence Number: 18421291
• Product Code: FMG
• UDI-Device Identifier: 00887709010079
• UDI-Public: (01)00887709010079(17)290701(10)14081471
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: B55005
• Device Lot Number: 14081471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: PROPOFOL, UNK MFR.
• Patient Sex: Unknown