MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 382-10

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed since the provided lot number is not valid for the product code.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint is reported as: there was an "air lock in the column causing volume loss to the column and bottle".It was also reported that the "volume increased 15ml on a patient with no change in pip, clamped top line and volumes dropped back to baseline." the column was replaced.There was no harm to the patient.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10567516
• MDR Text Key: 207951049
• Report Number: 3004365956-2020-00182
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 382-10
• Device Lot Number: 74E200084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NONE REPORTED.