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

Model Number	IPN049141
Medical Device Problem Codes	Break (1069); Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A visual inspection of the product involved in the complaint (customer "reported that; mr.(b)(6), physiotherapist (b)(6), was giving physiotherapy treatment to a patient in surgical ward, discovered that the triflo incentive spirometer had small broken pieces stuck in, preventing the second and third ball from going up during use".) could not be conducted since the product was not received yet at the manufacturing facility and no picture has been received for evaluation.A device history record review was performed, and no relevant findings were identified.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 or Problem Description
Customer reported that "reported by mr.(b)(6), physiotherapist (b)(6), was giving physiotherapy treatment to a patient in surgical ward, discovered that the triflo incentive spirometer had small broken pieces stuck in, preventing the second and third ball from going up during use".No patient injury or harm reported.Patient condition reported as "fine".New device used.
Additional Manufacturer Narrative
Qn #(b)(4).The device was returned for evaluation.A visual inspection was performed and it was observed that the sample was broken.What the customer is reporting as "small broken pieces stuck" it is actually a residue of the housing due to the damage issue.Even though customer complaint was confirmed as a damaged issue, it is not possible to assure that this damage was generated during the manufacturing process.100% functional testing and visual inspection is performed in the production line at the manufacturing facility prior to release; therefore, a defect of this type would be detected.Corrected data: section h6: medical device problem code corrected to 1069.
Event or Problem Description
Customer reported that "reported by mr.Kumar pillay ,physiotherapist s deoraj , was giving physiotherapy treatment to a patient in surgical ward, discovered that the triflo incentive spirometer had small broken pieces stuck in, preventing the second and third ball from going up during use".No patient injury or harm reported.Patient condition reported as "fine".New device used.

• Brand Name: TRIFLO II INCENTIVE DEEP BREATHING EXERC
• Common Device Name: SPIROMETER, THERAPEUTIC (INCEN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12554751
• Report Number: 3004365956-2021-00275
• Device Sequence Number: 3687299
• Product Code: BWF
• UDI-Device Identifier: 14026704626523
• UDI-Public: 14026704626523
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2025
• Device Model Number: IPN049141
• Device Catalogue Number: 8884717395
• Device Lot Number: 74L2000066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown