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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL TRIFLO II INCENTIVE DEEP BREATHING EXERC; SPIROMETER, THERAPEUTIC (INCEN
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TELEFLEX MEDICAL TRIFLO II INCENTIVE DEEP BREATHING EXERC; SPIROMETER, THERAPEUTIC (INCEN Back to Search Results
Model Number IPN049141
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  malfunction  
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 was performed on two pictures received by the customer of product code 8884717395 (triflo ii incentive deep breathing exercicer).One of them shows batch information of the reported product and the other one only shows a foreign object whose origin cannot be clearly determined with the image received; the reported failure mode is "a patient drew attention to himself that he felt something hard in his mouth when using the breathing trainer.It was a small piece of plastic.The origin cannot be clearly determined".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 Description
It was reported that "a patient drew attention to himself that he felt something hard in his mouth when using the breathing trainer.It was a small plastic piece.Origin cannot be clearly determined".No patient injury or harm reported.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn# (b)(4).The sample was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports: a visual inspection of the product involved in the complaint was performed on a received sample for evaluation of product code 8884717395 (triflo ii incentive deep breathing exerc).While performing the visual inspection test it was observed that one piece (residues of damage issues) of the finish good 8884717395 was received in a small plastic pouch that is not part of the manufacturing process.Additional since of use was observed since the corrugated tubing and mouthpiece were received assembled into the finish good, and a damage (broken issue) was observed on the right top corner of the device; the received plastic residue is part of the device since it fits well on the damage section.It is not possible to assure that this damage was generated during the manufacturing process therefore customer complaint cannot be confirmed as a manufacturing issue.
 
Event Description
It was reported that "a patient drew attention to himself that he felt something hard in his mouth when using the breathing trainer.It was a small plastic piece.Origin cannot be clearly determined".No patient injury or harm reported.Patient condition reported as "fine".
 
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Brand Name
TRIFLO II INCENTIVE DEEP BREATHING EXERC
Type of Device
SPIROMETER, THERAPEUTIC (INCEN
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12288013
MDR Text Key267230376
Report Number3004365956-2021-00256
Device Sequence Number1
Product Code BWF
UDI-Device Identifier14026704626523
UDI-Public14026704626523
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN049141
Device Catalogue Number8884717395
Device Lot Number74D2101518
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Date Manufacturer Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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