MAUDE Adverse Event Report: VYAIRE MEDICAL OY PATIENT HYTREL TUBE, ADULT, REUSABLE, 900 MM/ 35 IN, CONNECTORS 22/22 MM; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number	MANUAL VENT HOSE, REUSABLE, W BAG ARM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the 8004515 - manual vent hose, reusable, w bag arm was leaking during the procedure.There was no harm reported.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: PATIENT HYTREL TUBE, ADULT, REUSABLE, 900 MM/ 35 IN, CONNECTORS 22/22 MM
• Common Device Name: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, 52373 0; CH 523730
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15737783
• Report Number: 3010838917-2022-00020
• Device Sequence Number: 12342639
• Product Code: OFP
• UDI-Device Identifier: 10190752111653
• UDI-Public: (01)10190752111653
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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 Model Number: MANUAL VENT HOSE, REUSABLE, W BAG ARM
• Device Catalogue Number: 8004515
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 11/04/2022
• 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
• Patient Sex: Unknown