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

Catalog Number	RGH312U
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that while in use, the patient "chewed off the ends of the hme.Last night he almost swallowed the ends twice.He is constantly chewing off the ends of the hme, which, unfortunately, come off very easily.This episode happened at night, and luckily the father was able to retrieve the object before it did any damage.My client did not require any medical intervention and has done very well since".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that while in use, the patient "chewed off the ends of the hme.Last night he almost swallowed the ends twice.He is constantly chewing off the ends of the hme, which, unfortunately, come off very easily.This episode happened at night, and luckily the father was able to retrieve the object before it did any damage.My client did not require any medical intervention and has done very well since".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed , and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: TRACH-VENT+,CLEAN
• Common Device Name: CONDENSER, 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 17389507
• Report Number: 8040412-2023-00299
• Device Sequence Number: 3784256
• Product Code: BYD
• UDI-Device Identifier: 14026704717757
• UDI-Public: 14026704717757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: Health Professional
• Device Catalogue Number: RGH312U
• Device Lot Number: KMZ23A0389
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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 Age: 2 YR
• Patient Sex: Male