MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number ADAPTER VERSO ADULT/PED 45 DBL SWVL ELBO

Device Problem Material Separation (1562)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that at the start of endotracheal suctioning, in the process of inserting the suction catheter, the peep valve fell apart.The patient was sedated with a volatile anesthetic (isoflurane).The airlife¿ verso¿ airway access adapter was not broken or chipped.The end users secured two parts and replaced the valve.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.

Manufacturer Narrative

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 was received.H3 other text : device not returned yet.

Manufacturer Narrative

Results of investigation: vyaire medical was able to verify the reported issue.Based on the device history record (dhr), a nonconformance was identified during incoming quality control (iqc) for component 11761.The root cause was identified as the insufficient application of adhesive, where the amount of glue used was below the required rate upon reviewing the drawing for component 11761, it appears that there is no specified pulling test standard mentioned.

• Brand Name: AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PACIFIC HOSPITAL SUPPLY CO. LTD.; 4f, 160 daye rd. beitou distri; ct (owner operator address) no; taipei ; TW
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17374909
• MDR Text Key: 319787931
• Report Number: 3013421741-2023-00037
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752133815
• UDI-Public: (01)10190752133815(10)22023702
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADAPTER VERSO ADULT/PED 45 DBL SWVL ELBO
• Device Catalogue Number: CSC100
• Device Lot Number: 22023702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR
• Patient Sex: Male