MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-06 for NG SECURE 9304-1 manufactured by M.c. Johnson Company Inc.
[76733017]
Patient Sequence No: 1, Text Type: N, H10
[76733018]
Ng securement device in place, ng tube slipped out approximately 15 cm, reinserted to correct length, could have been prevented with better securement device, ng tube was then "chevron taped" to nose. This is a new product in our facility. We had two events in a 24 hour period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6613903 |
| MDR Report Key | 6613903 |
| Date Received | 2017-06-06 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-05-28 |
| Report Date | 2017-06-05 |
| Date Reported to FDA | 2017-06-05 |
| Date Reported to Mfgr | 2017-06-05 |
| Date Added to Maude | 2017-06-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | NG SECURE |
| Generic Name | NG SECURING DEVICE |
| Product Code | BSS |
| Date Received | 2017-06-06 |
| Catalog Number | 9304-1 |
| Lot Number | 1889 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | M.C. JOHNSON COMPANY INC |
| Manufacturer Address | 8801 BUSINESS PARK DR. SUITE 201 FORT MYERS FL 33912 US 33912 |
| Brand Name | NG SECURE |
| Generic Name | NG SECURING DEVICE |
| Product Code | KGX |
| Date Received | 2017-06-06 |
| Catalog Number | 9304-1 |
| Lot Number | 1889 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | M.C. JOHNSON COMPANY INC |
| Manufacturer Address | 8801 BUSINESS PARK DR. SUITE 201 FORT MYERS FL 33912 US 33912 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-06 |