MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-13 for HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER 8884717301 manufactured by Teleflex Medical.
[57350127]
(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.
Patient Sequence No: 1, Text Type: N, H10
[57350128]
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.
Patient Sequence No: 1, Text Type: D, B5
[61046216]
(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.
Patient Sequence No: 1, Text Type: N, H10
[61046217]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2016-00952 |
| MDR Report Key | 6027108 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-13 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-10-03 |
| Date Mfgr Received | 2016-11-29 |
| Date Added to Maude | 2016-10-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER |
| Generic Name | INCENTIVE SPIROMETER |
| Product Code | BWF |
| Date Received | 2016-10-13 |
| Returned To Mfg | 2016-10-17 |
| Catalog Number | 8884717301 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-13 |