MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for MEDICAL ACTION INDUSTRIES 75378 manufactured by Medical Action Industries Inc..
[161522140]
Trach care tray opened at bedside to find that the saline container was empty and there is brown/yellow colored, dried fluid all over the inside contents. Tray completely unusable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9165655 |
| MDR Report Key | 9165655 |
| Date Received | 2019-10-08 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-09-13 |
| Report Date | 2019-09-24 |
| Date Reported to FDA | 2019-09-24 |
| Date Reported to Mfgr | 2019-10-08 |
| Date Added to Maude | 2019-10-08 |
| 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 | MEDICAL ACTION INDUSTRIES |
| Generic Name | TRACHEOTOMY CARE KIT |
| Product Code | NXA |
| Date Received | 2019-10-08 |
| Model Number | 75378 |
| Catalog Number | 75378 |
| Lot Number | 259371 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES INC. |
| Manufacturer Address | 25 HEYWOOD RD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-08 |