MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	AC205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a medsun mandatory medwatch report (mdr report #: (b)(4)) that a 5 gang 4-way nanoclave¿ stopcock w/baseplate, rotating luer generated a leak.¿from staff: patient arrived from operating room (or), about 10 minutes after arrival, manifold tubing that carried medications to patient cracked and leaked.Iv vasopressors did not infuse into patient so no response to titration.Patient in near arrest, required iv bolus of epinephrine for hypotension.Puddle with blood and fluid found on floor.Iv vasopressors were then given via peripheral line with large increase in blood pressure.Blood pressure very labile after incident.Manifold changed to a new manifold.¿ there was no death or serious injury reported.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
Correction in h10.Added report # (b)(4) from this field box.
Additional Manufacturer Narrative
The complaint on the ac205 could not be confirmed by the investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for lot 13887310 was reviewed and no nonconformities were found that would have led to the reported complaint.D9 device available for evaluation: no.
Additional Manufacturer Narrative
The investigation was updated with the following information: investigation summary: received one (1) used ac205 5 gang 4-way nanoclave stopcock for inspection.As received, a nanoclave was separated from the manifold.The nanoclave was separated at the area of the ultrasonic weld.The other ports were tested for bond integrity per product specifications.Each bond met functional specifications.Two (2) of the bonds were tested under a bending force with a perpendicular load.One (1) broke at the uv adhesive bond.The other sample broke at the ultrasonic weld.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.The dhr for lot 13887310 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 5 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, 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: 19442664
• Report Number: 9617594-2024-00717
• Device Sequence Number: 8545120
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)290101(10)13887310
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AC205
• Device Lot Number: 13887310
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 07/26/2024; 04/11/2025
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 06/10/2024; 07/29/2024; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: EPINEPHRINE, UKN MFR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 110 KG