MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS BREATHING CIRCUIT, EXPANDABLE, ADULT, DISPOSABLE, 1.8 M/72 IN; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number CIRCUIT E(A) 1.8M 1.5M-EXT 2L BAG GSE

Device Problem Gas/Air Leak (2946)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.

Event Description

It was reported to vyaire medical that the circuit e(a) 1.8m 1.5m-ext 2l bag gse have leaks.Furthermore, there is no information regarding patient involvement.

Event Description

It was reported to vyaire medical that the circuit e(a) 1.8m 1.5m-ext 2l bag gse have leaks.Furthermore, there is no information regarding patient involvement.

Manufacturer Narrative

Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if addition information becomes available.Issue was confirmed based on the picture provided by the customer.Based on the picture it is clear that the tube has been damaged.It is however not possible to determine at which point this damage has occurred.It is also not possible to determine if the damage goes through the product causing the leak, but this is possible.Production process includes leak test that would catch a leaking product.Thereby it is very unlikely that the damage would have been caused during production.The most likely cause of the damage is rough handling of the product package, or rough handling of the product by the user.

• Brand Name: VITAL SIGNS BREATHING CIRCUIT, EXPANDABLE, ADULT, DISPOSABLE, 1.8 M/72 IN
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; etela-suomen laani; helsinki ; FI
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan ; CH
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18727890
• MDR Text Key: 336629308
• Report Number: 3010838917-2024-00105
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CIRCUIT E(A) 1.8M 1.5M-EXT 2L BAG GSE
• Device Catalogue Number: M1090619
• Device Lot Number: 230804
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other