MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ PATIENT HYTREL TUBE, ADULT, REUSABLE 900 MM/ 35 IN, CONNECTORS 22/2; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number VITAL SIGNS¿ PATIENT HYTREL TUBE, ADULT, REUSABLE 900 MM/ 35 IN, CONNECTORS 22/2

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Pma/ 510(k): enforcement discretion.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported gas is leaking from around the seam of the manual bag hose of the 8004515 vital signs¿ patient hytrel tube, adult, reusable 900 mm/ 35 in, connectors 22/2.The customer confirmed that it was used to a patient and there is no harm done to the patient.

• Brand Name: VITAL SIGNS¿ PATIENT HYTREL TUBE, ADULT, REUSABLE 900 MM/ 35 IN, CONNECTORS 22/2
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; dongguan, 52373 0; CH 523730
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13343077
• MDR Text Key: 287820002
• Report Number: 3004050971-2022-00021
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAL SIGNS¿ PATIENT HYTREL TUBE, ADULT, REUSABLE 900 MM/ 35 IN, CONNECTORS 22/2
• Device Catalogue Number: 8004515
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1