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

Catalog Number G41312

Device Problem Disconnection (1171)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that, when the user attempted to connect the trach-vent to the tracheostomy tube, the trach-vent could be inserted into the tube only about 2mm and got detached immediately.The user opened a new unit, but the same issue occurred.Therefore, the third unit was used to complete the procedure.Additional information states that although the patient sustained desaturation during this event, there was no harm or injury to the patient.No medical intervention required.When asked, the customer did not know the percentage of desaturation that occurred.The patient status is reported as "fine".See associated mdr 8040412-2023-00138.

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "based on the returned samples provided, 15mm plug gauge test was conducted on the connector of the sample.The connector side is in the specification according to iso 5356-1:2015.In current manufacturing procedure, iqc department will conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area 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." the complaint could not be confirmed.No issues were found with the returned sample and a review of the device history records showed no relevant findings.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that, when the user attempted to connect the trach-vent to the tracheostomy tube, the trach-vent could be inserted into the tube only about 2mm and got detached immediately.The user opened a new unit, but the same issue occurred.Therefore, the third unit was used to complete the procedure.Additional information states that although the patient sustained desaturation during this event, there was no harm or injury to the patient.No medical intervention required.When asked, the customer did not know the percentage of desaturation that occurred.The patient status is reported as "fine".See associated mdr 8040412-2023-00138.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16776369
• MDR Text Key: 313653240
• Report Number: 8040412-2023-00178
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G41312
• Device Lot Number: KMZ21B0752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• 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