MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT COMPACT S; CONDENSER, HEAT AND MOISTURE

Catalog Number 19401

Device Problem Leak/Splash (1354)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that: 1 dec 2023, before using the product for the patient, it was found to have air leakage.A new package was opened.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The sample was returned to the manufacturer for investigation.The manufacturer reported: "one sample and a photo from the customer in sap were reviewed for investigation.During visual analysis, a clear droplet was observed inside the sealed pouch.The complaint reported that it was found droplets in packaging.Device was assembled correctly.Based on the investigation conducted on the returned sample, the sample has clear droplets inside the pouch.Pouch is seal upon received.Condensation has happened in the product packaging where temperature fluctuations occur along transportation or storage condition.This will result in condensation inside the product package.In current manufacturing procedure, 100% leak testing and visual inspection after assembly process is conducted.Thus, any ineffective products will be culled out during this process.No material or process change for this product based on the history change record.No similar defect found at manufacturing site.Therefore, it is very unlikely condition at the manufacturing area that the product having droplets to be released for shipment.Customer complained that the product having droplets.But as per visual inspection on returned sample, there are droplets in the packaging cause by condensation during temperature fluctuation from storage condition.Hence, this complaint could not be confirmed." teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: (b)(6) 2023, before using the product for the patient, it was found to have air leakage.A new package was opened.

• Brand Name: HUMID VENT COMPACT S
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18397264
• MDR Text Key: 331393936
• Report Number: 8040412-2023-00421
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 19401
• Device Lot Number: KMH22L0166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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