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

Catalog Number 41311

Device Problem Contamination (1120)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "when doing clinical check before use on patient, it is found that there are black stains on the filter element of the filter".No patient involvement reported.

Manufacturer Narrative

(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return, and no photo was provided for evaluation.The manufacturer has reported that "according to internal acceptance criteria, a black spot or stain shall be rejected as long as the size is less than 0.3mm compare to tappi chart".However without the returned sample this could not be verified.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.

Event Description

It was reported that "when doing clinical check before use on patient, it is found that there are black stains on the filter element of the filter".No patient involvement reported.

• Brand Name: HUDSON TRACH-VENT ,STERILE
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11058348
• MDR Text Key: 223768386
• Report Number: 8040412-2020-00278
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 41311
• Device Lot Number: 19JT24
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1