MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for OG TUBE 0046160 manufactured by Bard / C. R. Bard, Inc..
[175666167]
Pt admitted with og tube from ed. This am nurse (b)(6) noticed og leaking in between air vent pigtail. Later in the afternoon the new og tube is leaking again at the same spot. A new 16 fr is inserted. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092243 |
| MDR Report Key | 9592272 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-13 |
| Date Added to Maude | 2020-01-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OG TUBE |
| Generic Name | TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND / OR INTUBATION |
| Product Code | FEG |
| Date Received | 2020-01-14 |
| Model Number | 0046160 |
| Catalog Number | 0046160 |
| Lot Number | NGDT3047 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD / C. R. BARD, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |