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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of cracks on item ac205 cannot be confirmed.Since 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 probable cause cannot be determined.The device history review (dhr) review couldn't be performed due to the lot number for this complaint was unknown.
Event or Problem Description
It was reported that, on an unknown date in august, a 5 gang 4-way nanoclave¿ stopcock w/baseplate, rotating luer was found to have been broken resulting in a leak during patient use.It was reported, ¿broken manifold on cardiac or patient that arrived to ccu.Iv drugs were not infusing properly and leaking all over the floor and placing patient at risk for air embolism and it was caught before harm reached patient that has a hypertension.¿ the event occurred at the hospital user facility.There was no patient harm reported.

• 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. ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20532258
• Report Number: 9617594-2024-01498
• Device Sequence Number: 18224030
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: 00887709080010
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: 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: 09/27/2024
• Initial Report FDA Received Date: 10/25/2024
• 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: UNSPECIFIED FLUID, UNK MFR.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 89 KG