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 2016-11-18 for HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV 1734 manufactured by Teleflex Medical.
[60302884]
(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. A dhr review could not be conducted since the lot number was not provided. A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident. 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. However material from the production line was functionally tested and no issues were detected that can lead to this customer complaint. If the device sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[60302885]
The customer alleges that the device does not nebulize the medication. The alleged issue was detected prior to patient use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00426 |
| MDR Report Key | 6112333 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-18 |
| Date of Report | 2016-11-07 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2016-11-18 |
| 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 | 2016-11-18 |
| Catalog Number | 1734 |
| Lot Number | UNKNOWN |
| 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 | 2016-11-18 |