MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - 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.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that when the patient was sedated for intubation the endotracheal (et) tube was placed by anesthesia and hooked up to the circuit.When the patient was manually ventilated, it sounded like there was a leak in the b1714xxx anes circuit, ped, 108 in exp, 1l bag.The anesthesiologist noted there was not good ventilation.The patient was extubated and ventilated using a bag valve mask while the circuit tubing and bag were replaced.Afterwards, the sound of the leak was gone and better ventilation was achieved.More medication was provided to sedate for intubation was done and the et was replaced with good seal in the tube and the circuit was ventilating as it should be.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
Additional Manufacturer Narrative
Vyaire medical was able to verify the reported issue.The returned sample undergo a functionally inspection performing a leak test and the sample failed this test, discovering a hole in the tube that was causing the leak issue.We determined that manufacturing process is related with the reported defect.The instructions of evaluating de conditions of the extruder production line and conditions of the extruder block chain are established.

• Brand Name: VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17263966
• Report Number: 8030673-2023-00333
• Device Sequence Number: 18120596
• Product Code: CAI
• UDI-Device Identifier: 10190752124004
• UDI-Public: (01)10190752124004(10)0004226339
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: B1714XXX
• Device Lot Number: 0004226339
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 21 KG