MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 8884717301

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned to the manufacturer at the time of this report.(b)(6) samples of a device from the same family were taken from the current production and functionally inspected.The issue reported "therapy ball is stuck" was not observed in the current manufacturing process.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted and no update is required.Customer complaint cannot be confirmed.It is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect and determine a root cause.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges "when carrying out one respiratory therapy of the balls is stuck, al looking there is a plastic that does not allows to slide." there was no report of patient injury or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for investigation.A visual exam was performed and it was observed that two pieces of plastic were in the 2nd tube (900cc) along with the ball.One smaller piece of plastic was in the 3rd tube (1200cc) along with the ball.It was observed that the pieces of plastic were the pins that broke off of the top of the 1st tube (600cc).Upon functional inspection, it was found that the broken pieces of plastic caused the balls to get stuck in the tubes.It could not be determined what caused the plastic pins to break.It is possible that the pins broke during shipping or due to rough handling of the device.The reported complaint of "therapy ball is stuck" was confirmed based upon the sample received.Functional inspection of the device revealed that the plastic pins at the top of the 1st tube (600cc) were broken and the pieces went into the other two tubes which caused the balls to get stuck.It is possible that the pins broke during shipping or due to rough handling of the device.However, it could not be determined how or when the pins broke.The triflo ii incentive breathing exerciser is 100% inspected during manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Other remarks: a device history record review was performed on the device with no evidence to suggest a manufacturing related issue.The root cause of this complaint is undetermined as it could not be determined how or when the pins broke off of the device.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges "when carrying out one respiratory therapy of the balls is stuck, al looking there is a plastic that does not allows to slide." there was no report of patient injury or consequence.

• Brand Name: HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7096421
• MDR Text Key: 94154904
• Report Number: 3003898360-2017-01245
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8884717301
• Device Lot Number: 73K1600551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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