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 2015-12-29 for HUDSON MICROMIST NEBULIZER,W/IN-LINE NEBTEE VL 41745 manufactured by Teleflex Medical.
[34602144]
(b)(4). Actual lot# is unknown. Lot#'s sold to customer: 74a1502371, 74h1500133 and 74g1501374. A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned. The device history records of batch numbers (b)(4) that belong to catalog number 41745 have 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's showed that the product was assembled & 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, 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
[34602185]
The customer alleges that the nebulizer is leaking.
Patient Sequence No: 1, Text Type: D, B5
[38324005]
(b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. Functional testing was also performed and no issues were detected. The sample was found to be within specification. As an additional test, the sample was cleaned up and placed on the nebulization fixture for 1. 5 hours and no leakage was observed. Based on the investigation performed, the reported complaint could not be confirmed. There were no issues found with the returned device.
Patient Sequence No: 1, Text Type: N, H10
[38324006]
The customer alleges that the nebulizer is leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00425 |
| MDR Report Key | 5332629 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-29 |
| Date of Report | 2015-12-21 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2016-02-11 |
| Date Added to Maude | 2015-12-29 |
| 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 MICROMIST NEBULIZER,W/IN-LINE NEBTEE VL |
| Generic Name | NEBULIZER, NON-VENTILATORY |
| Product Code | CCQ |
| Date Received | 2015-12-29 |
| Returned To Mfg | 2016-01-12 |
| Catalog Number | 41745 |
| Lot Number | UNKNOWN |
| 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 | 2015-12-29 |