MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for ROBERTAZZI NASOPHARYNGEAL AIRWAY 1-5075-34 manufactured by Sunmed Holdings, Llc.
[174509557]
Routine checks of the emergency department (ed) airway carts by nursing - concerns about our nasal airways feeling stiff and "crunchy. " not outdated. When packaged opened, plastic is hard and visible cracks noted when airway is manipulated. Airway is meant to be soft and pliable, as it is inserted into the nasal passage. These are stored on the top of each airway cart in the room. Wondering if because they are exposed to fluorescent light 24/7 that might have something to do with it? It's been this way for years and we've never noticed it before though. So maybe something changed in how the product is made?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9574332 |
| MDR Report Key | 9574332 |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-23 |
| Report Date | 2019-12-26 |
| Date Reported to FDA | 2019-12-26 |
| Date Reported to Mfgr | 2020-01-10 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROBERTAZZI NASOPHARYNGEAL AIRWAY |
| Generic Name | AIRWAY, NASOPHARYNGEAL |
| Product Code | BTQ |
| Date Received | 2020-01-10 |
| Model Number | 1-5075-34 |
| Catalog Number | 1-5075-34 |
| Lot Number | MD041 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED HOLDINGS, LLC |
| Manufacturer Address | 2710 NORTHRIDGE DRIVE NW SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |