MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT; VENTILATOR BREATHING CIRCUIT, SINGLE-USE

Model Number	CIRCUIT RESP INFANT 4FT UNHTD 30/CS
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the water trap was difficult to remove from the 6800-503 circuit resp infant 4ft unhtd 30/cs.The event occurred during use.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.On follow-up, it was confirmed that the customer changed the circuit to prevent patient injury/harm.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Results of investigation:the device history record of the fg infant resp circ 4 ft part number 6800-503 with lot number 0004207263 and the device history record of the part number float style water trap part number 3185 with lot number 1306333 were reviewed, and no issues were found.A closed physical sample was received of the fg infant resp circ 4 ft with lot number 0004207263 was visually inspected was visually inspected and no defects were found on the sample recived.Material may be involved in the defect.We found out that the tank, float water trap part number 65-2054a, and body, float water trap part number 65-2011a, are difficult to disassemble.A quality notification (qn-2023-006) was sent to the supplier of both components for further investigation.In addition, manufacturing personnel may be related to the reported defect because the assembly between parts 65-2054a and 65-2011a is performed manually.If manufacturing personnel assembly is too hard, a defect like the one reported in this complaint could occur.In the video received, we could observe the customer trying to disassembly the water trap with circular movements as if it were threaded, but we recommend disassembly performing movements side to side to separate the tank float water trap part number 65-2054a from the body float water trap part number 65-2011a.Additionally, it was reviewed to see if there were previous reports in the last 3 years related to the defect in this complaint.No trend was found.The root cause was not determined.However, vyaire will continue to monitor and follow up on the reported defect.

• Brand Name: AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT
• Common Device Name: VENTILATOR BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 686561-5500
• MDR Report Key: 15831528
• Report Number: 8030673-2022-00280
• Device Sequence Number: 12030031
• Product Code: BZE
• UDI-Device Identifier: 10190752157408
• UDI-Public: (01)10190752157408(10)0004207263
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2022

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: CIRCUIT RESP INFANT 4FT UNHTD 30/CS
• Device Catalogue Number: 6800-503
• Device Lot Number: 0004207263
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/20/2022
• Supplement Report FDA Received Date: 11/09/2023
• 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 Sex: Unknown