MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON TRACH-VENT+,CLEAN; HUMID-VENT HEAT AND MOISTURE

Model Number	IPN044418
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "there was an extra valve included in the humidifier rendering the product useless and obstructing our patients airway".Device was used in the home environment.Additional information received stated that the patient has an existing trachy and the issue was corrected by removing the defective device and replacing it.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "there was an extra valve included in the humidifier rendering the product useless and obstructing our patients airway".Device was used in the home environment.Additional information received stated that the patient has an existing trachy and the issue was corrected by removing the defective device and replacing it.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided photos for evaluation.The photos were reviewed and it was found that the device has an extra silicone valve.The manufacturing site reports that further investigation could not be conducted to identify the root cause of the defect as the sample was not returned and no lot number was provided.The manufacturing site also reports "in current manufacturing procedure, 100% light test during packing process is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.".

• Brand Name: HUDSON TRACH-VENT+,CLEAN
• Common Device Name: HUMID-VENT HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14407114
• Report Number: 8040412-2022-00112
• Device Sequence Number: 16783692
• Product Code: BYD
• UDI-Device Identifier: 04026704348176
• UDI-Public: 04026704348176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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
• Device Model Number: IPN044418
• Device Catalogue Number: 41312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown