MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-15 for HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV 1734 manufactured by Teleflex Medical.
[59877587]
(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 for evaluation. No photo for review. The device history record of batch number (b)(4) that belong to catalog number 1734 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. A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause without the device sample. Customer complaint cannot be confirmed based only on the information provided. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code and it is not being manufactured at the time. If the sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[59877588]
The customer alleges that the device is not misting/nebulizing during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00422 |
| MDR Report Key | 6102359 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-15 |
| Date of Report | 2016-11-04 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2016-11-04 |
| Date Added to Maude | 2016-11-15 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| 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 UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV |
| Generic Name | NEBULIZER, NON-VENTILATING |
| Product Code | CCQ |
| Date Received | 2016-11-15 |
| Catalog Number | 1734 |
| Lot Number | 74J1601377 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |