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	05/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 14" (36 cm) ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext where it was reported that the red port of 4-port manifold used for continuous infusion of propofol was leaking.Upon admission to the cvicu the red port was noted to be visibly leaking from the top of the port.It was also stated there was a risk that the patient may not have been receiving the appropriate amount of propofol.There was patient involvement, however no patient harm and no delay in therapy.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.E1 initial reporter phone number: ext.(b)(6).
Additional Manufacturer Narrative
Investigation summary: a photo was provided showing leakage from the red port from the white button.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 device was not returned.The device history review could not be reviewed due to the unknown lot number.

• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19564104
• Report Number: 9617594-2024-00780
• Device Sequence Number: 6974312
• Product Code: FMG
• UDI-Device Identifier: 00887709010079
• UDI-Public: (01)00887709010079
• 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): 12/26/2024

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: 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: 05/22/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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