MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-12-11 for HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV 1734 manufactured by Teleflex Medical.
[33263992]
(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 at this time. No photo for review. The device history record was reviewed and showed 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, in order to perform a proper investigation it is necessary to evaluate the sample involved in 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. If device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[33263993]
The customer alleges that the nebulizer is leaking around the tubing and popping off. No patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00411 |
| MDR Report Key | 5288927 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-12-11 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2015-12-01 |
| Device Manufacturer Date | 2015-07-16 |
| Date Added to Maude | 2015-12-11 |
| 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 | 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-VENTILATORY |
| Product Code | CCQ |
| Date Received | 2015-12-11 |
| Catalog Number | 1734 |
| Lot Number | 74G1501326 |
| 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 | 2015-12-11 |