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

Catalog Number 8884717301

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2016

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 has not been returned at the time of this report.Thirteen samples were taken from the current production (8884717395) lot # 73j1600663, a quality inspection was performed on the samples, and issue reported "air leakage" was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number for the device involved was not provided.Corrective actions cannot be established as it is necessary to receive the device sample to perform a proper investigation , and confirm the alleged defect.Customer complaint cannot be confirmed.The root cause is unknown at this time.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

The customer alleges that air leakage from the product was confirmed during use.No harm or injury to patient was reported.The patient condition was reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was also performed and no leaks were detected.The reported complaint of "air leakage during use on patient" was not confirmed based upon the sample received.The returned breathing exerciser was able to pass a functional inspection when connected to vacuumed air.All three inner balls were able to move within the breathing exerciser when the flowmeter was set to the appropriate pressure.There were no functional issues found with the returned sample.No further action will be taken.

Event Description

The customer alleges that air leakage from the product was confirmed during use.No harm or injury to patient was reported.The patient condition was reported as fine.

• Brand Name: HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER
• Type of Device: INCENTIVE SPIROMETER
• 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: 6027108
• MDR Text Key: 57350127
• Report Number: 3003898360-2016-00952
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8884717301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1