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 2016-09-08 for HUDSON MICROMIST NEBULIZER,W/IN-LINE NEBTEE VL 41745 manufactured by Teleflex Medical.
[54268235]
(b)(4). A visual inspection of the product involved in the complaint was performed on a picture provided by the customer. A short metal tube with a rounded end can be observed. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. A device history record review was conducted and showed that the product was assembled & inspected according to our specifications. The visual inspection test was performed on the picture provided the customer however only a short metal tube with a rounded end was observed. 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 customer complaint. If the device sample becomes available at a later date this complaint will be updated.
Patient Sequence No: 1, Text Type: N, H10
[54268236]
The customer alleges that the oxygen tubing is popping off at the ventilator connection. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00346 |
| MDR Report Key | 5937374 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-08 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-08-24 |
| Device Manufacturer Date | 2016-04-13 |
| Date Added to Maude | 2016-09-08 |
| 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 MICROMIST NEBULIZER,W/IN-LINE NEBTEE VL |
| Generic Name | NEBULIZER |
| Product Code | CCQ |
| Date Received | 2016-09-08 |
| Catalog Number | 41745 |
| Lot Number | 74D1601724 |
| 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 | 2016-09-08 |