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

Model Number	IPN044386
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported: the "patient experienced throat swelling and red mark after using product".Device removed and a different device was used.Additional information stated that patient had small abrasion from the device.Polysporin topical treatment used.No serious or permanent injury reported.
Event or Problem Description
It was reported: the "patient experienced throat swelling and red mark after using product".Device removed and a different device was used.Additional information stated that patient had small abrasion from the device.Polysporin topical treatment used.No serious or permanent injury reported.
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no abnormalities were found.The product was assembled correctly.A device history record review was performed on the lot number reported and no relevant findings were identified.The manufacturing site reports that a 100% visual exam is conducted after the assembly process; therefore, any defects would be detected prior to release from the manufacturing facility.The complaint report states that the device was used for one and a half weeks on the patient.The ifu for this product states to replace every 24 hours or as needed to prevent accumulation of secretions.In addition, the trach vent is designed for single use only and must not be cleaned and reused.Reuse of the device creates a potential risk of serious injury or infection.Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality.The complaint could not be confirmed as there were no issues found with the returned device.

• Brand Name: HUDSON HV TRACH
• 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: 13497529
• Report Number: 8040412-2022-00040
• Device Sequence Number: 4113389
• Product Code: BYD
• UDI-Device Identifier: 04026704348145
• UDI-Public: 04026704348145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2025
• Device Model Number: IPN044386
• Device Catalogue Number: 41112
• Device Lot Number: KMZ20M0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2020
• 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
• Patient Sex: Unknown