MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-05 for HUDSON INCENTIVE SPIROMETER 1750 manufactured by Teleflex Medical.
[38117753]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record of batch number (b)(4) that belong to catalog number 1750 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. No non conformance reports were originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled and inspected according to our specifications. No corrective action can be established at this moment since the device sample and/or picture are not available for evaluation. Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint. If the device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[38117754]
The end-user alleges that the inward air-let appears to be blocked as air does not enter and lift the ball. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[41063192]
(b)(4). One unit of catalog number 1750 (incentive spirometer) was received for analysis. A visual exam was performed and it was observed that the valve was incorrectly assembled. Functional testing was also performed and the sample failed due to the incorrect valve assembly. Based on the investigation performed, the reported complaint was confirmed. It was found that the valve on the sample was assembled incorrectly at the manufacturing facility. As a corrective action, new equipment will be implemented in the assembly process line to help to assure the correct assembly of the valve. This corrective action will be performed and implemented on july 22th, 2016. Also, as an immediate action, personnel involved in the manufacturing process was notified about this complaint.
Patient Sequence No: 1, Text Type: N, H10
[41063193]
The end-user alleges that the inward air-let appears to be blocked as air does not enter and lift the ball. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00112 |
| MDR Report Key | 5413159 |
| Date Received | 2016-02-05 |
| Date of Report | 2016-01-26 |
| Date of Event | 2015-12-28 |
| Date Mfgr Received | 2016-03-22 |
| Device Manufacturer Date | 2015-04-16 |
| Date Added to Maude | 2016-02-05 |
| 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 | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON INCENTIVE SPIROMETER |
| Generic Name | INCENTIVE SPIROMETER |
| Product Code | BWF |
| Date Received | 2016-02-05 |
| Returned To Mfg | 2016-02-11 |
| Catalog Number | 1750 |
| Lot Number | 74D1502238 |
| Operator | LAY USER/PATIENT |
| 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 | 2016-02-05 |