MAUDE Adverse Event Report: VYAIRE MEDICAL VYAIRE MEDICAL; STRAIGHT CONN 22ODX22ID,W/PORT

Model Number	004081
Medical Device Problem Codes	Connection Problem (2900); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The plastic cap that is attached does not stay closed and pops open with any breath delivered by the ventilator. report indicates this is adverse event, but does not indicate adverse effect on the patient.
Additional Manufacturer Narrative
Reportable as this could cause an air link and delay patient ventilation.
Additional Manufacturer Narrative
Reportable as this could cause an air link and delay patient ventilation.The complaint of "the plastic cap that is attached does not stay closed and pops open with any breath delivered by the ventilator." regarding part 004081 was not confirmed.The root cause was not determined.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
The plastic cap that is attached does not stay closed and pops open with any breath delivered by the ventilator. report indicates this is adverse event, but does not indicate adverse effect on the patient.

• Brand Name: VYAIRE MEDICAL
• Common Device Name: STRAIGHT CONN 22ODX22ID,W/PORT
• Manufacturer (Section D): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18965559
• Report Number: 8030673-2024-01003
• Device Sequence Number: 12802153
• Product Code: BZA
• UDI-Device Identifier: 10190752152595
• UDI-Public: 10190752152595
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 004081
• Device Catalogue Number: 004081
• Device Lot Number: 0004254980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 04/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown