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

Catalog Number 8884717301

Device Problem Air Leak (1008)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Thirteen samples were taken from the actual production (triflo ii incentive deep breathing exerc) lot # 73g1600654, a quality inspection was performed on the samples according to the procedures (b)(4), and no quality issues were found on the samples.A device history record investigation was conducted and did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time , since the sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.If the alleged device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

The customer alleges an air leak from the device.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no leaks were detected.The reported complaint of an air leakage from the product was not confirmed based upon the sample received.The returned breathing exerciser was able to pass a functional inspection when connected to vacuumed air.A dhr review was performed on the lot number with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned sample.No further action will be taken.

Event Description

The customer alleges an air leak from the device.

• 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: 5880150
• MDR Text Key: 52617927
• Report Number: 3003898360-2016-00779
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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: 73F1500194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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