MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER; SPIROMETER, THERAPEUTIC (INCEN

Model Number IPN049142

Device Problem Leak/Splash (1354)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.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 "the devices leaks air in the hoses when performing breathing exercises".No patient injury or harm reported.Patient condition unknown at time of report.

• Brand Name: HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER
• Type of Device: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12638841
• MDR Text Key: 276600850
• Report Number: 3004365956-2021-00290
• Device Sequence Number: 1
• Product Code: BWF
• UDI-Device Identifier: 14026704626530
• UDI-Public: 14026704626530
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN049142
• Device Catalogue Number: 8884717301
• Device Lot Number: MD20623802
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• 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: N/A.