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 2016-08-16 for HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER 8884717301 manufactured by Teleflex Medical.
[52617927]
(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.
Patient Sequence No: 1, Text Type: N, H10
[52617928]
The customer alleges an air leak from the device.
Patient Sequence No: 1, Text Type: D, B5
[55600054]
(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.
Patient Sequence No: 1, Text Type: N, H10
[55600055]
The customer alleges an air leak from the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2016-00779 |
| MDR Report Key | 5880150 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-16 |
| Date of Report | 2016-07-27 |
| Date of Event | 2016-07-25 |
| Date Mfgr Received | 2016-09-21 |
| Device Manufacturer Date | 2015-06-09 |
| Date Added to Maude | 2016-08-16 |
| 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 | 2016-08-16 |
| Returned To Mfg | 2016-08-12 |
| Catalog Number | 8884717301 |
| Lot Number | 73F1500194 |
| 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 | 2016-08-16 |