MAUDE Adverse Event Report: NULL THERMOVENT T - HEAT AND MOISTURE EXCHANGER; CONDENSER, HEAT AND MOISTURE

Catalog Number 100/570JCZ

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/01/2020

Event Type  malfunction  

Event Description

It was reported that before opening the package, the customer noticed a hair inside the package.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.No product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The suspect device was received for investigation.Under visual inspection we noticed that there is app.8,5mm long hair inside not opened unit pack.Such defect is clearly manufacturing error.Affected piece would not pass 100% visual inspection which is done after packaging in boxing area.No trend of similar customer complaints was identified.To increase operators awareness about this complaint we issued quality alert with complaint description and with names of operators who were inspecting affected batch.Quality alert will be placed in boxing area for one month.Udi is unknown, operator of device is unknown, this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: THERMOVENT T - HEAT AND MOISTURE EXCHANGER
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section G): NULL
• MDR Report Key: 15445159
• MDR Text Key: 305266197
• Report Number: 3012307300-2022-19590
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K874597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 100/570JCZ
• Device Lot Number: 3900020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1