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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a 5 gang 4-way nanoclave® stopcock w/baseplate, rotating luer.The customer reported that ¿6 port iv paddle disconnected from patient introducer on its' own.Patient went without important iv medication for some unknown amount of time.Additional information was received stating "the patients' epi became disconnected and the patients¿ blood pressure dropped to the 60¿s systolic for several minutes until the charge nurse noticed that the gown was wet and the medication was leaking and iv tubing was disconnected and immediately reconnected; this was from their cvicu on post-op patient.The reference number is (b)(4), provided lot number (10)24043003.There was patient involvement, but harm was not reported as a consequence of this event.

• 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: 19532981
• Report Number: 9617594-2024-00757
• Device Sequence Number: 7681101
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)290401(10)13953105
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 06/13/2024

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: AC205
• Device Lot Number: 13953105
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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, MFR UNK
• Patient Sex: Unknown