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 2017-05-16 for LMA MAD NASAL WITHOUT SYRINGE MAD300 manufactured by Teleflex Medical.
[75236844]
(b)(4). No sample device was returned at the time of this report. There was no photo for review. Therefore no testing or physical evaluation was able to be performed. A device history record review for the device lot number reported showed no issues related to this complaint. All testing methods performed by qa on this batch were found to be acceptable. The customer complaint cannot be confirmed based only on the information received. If the device becomes available at a later date this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[75236845]
Customer complaint alleges the "anesthetic could not be sprayed out from the atomizer". Alleged malfunction reported to have occurred during use. A new device was used instead. It was reported there was no medical intervention necessary. Patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
[96241717]
(b)(4). The sample was returned for evaluation. A visual exam was performed on the sample was it was observed that there was an occlusion on the tip. Functional testing was also performed and the occlusion was confirmed. A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint. Based on the investigation performed, the reported complaint was confirmed. The root cause is attributed to excessive solvent on the tip, causing a blockage of the atomization hole. This operation is done manually, the root cause is related to operator error. This is considered to be an isolated event as the product was manufactured 29-oct-2015 and no other complaints for this issue have been received from june 2014 to present. A non-conformance was opened to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[96241718]
Customer complaint alleges the "anesthetic could not be sprayed out from the atomizer". Alleged malfunction reported to have occurred during use. A new device was used instead. It was reported there was no medical intervention necessary. Patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722554-2017-00002 |
| MDR Report Key | 6568572 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-16 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-06-16 |
| Date Added to Maude | 2017-05-16 |
| 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 | WOLFE TORY MEDICAL INC. |
| Manufacturer Street | 79W 4500 S SUITE 18 |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA MAD NASAL WITHOUT SYRINGE |
| Generic Name | NEBULIZER, MEDICINAL,NON-VENTILATORY |
| Product Code | CCQ |
| Date Received | 2017-05-16 |
| Returned To Mfg | 2017-05-30 |
| Catalog Number | MAD300 |
| Lot Number | 151037 |
| Device Expiration Date | 2018-10-29 |
| 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 | 2017-05-16 |