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

Catalog Number RGH312U

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event 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 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".

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
• Type of Device: 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
• MDR Text Key: 319703674
• Report Number: 8040412-2023-00299
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 14026704717757
• UDI-Public: 14026704717757
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RGH312U
• Device Lot Number: KMZ23A0389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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: 2 YR
• Patient Sex: Male