MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER 0046160 manufactured by C. R. Bard, Inc..
[141591379]
Nasogastric tube currently used in the emergency department are very difficult to visualize on x-ray. A nasogastric tube was placed in a patient for gastrointestinal bleeding and placement was confirmed by auscultation and from the return of gastric contents but an x-ray did not demonstrate where that tube was placed. In the formal radiology reading the radiologist did not comment on the nasogastric tube because it was not radiographically visible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8503298 |
| MDR Report Key | 8503298 |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-22 |
| Report Date | 2019-03-26 |
| Date Reported to FDA | 2019-03-26 |
| Date Reported to Mfgr | 2019-04-11 |
| Date Added to Maude | 2019-04-11 |
| 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 |
| 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 | BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER |
| Generic Name | TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION |
| Product Code | FEG |
| Date Received | 2019-04-11 |
| Model Number | 0046160 |
| Catalog Number | 0046160 |
| Lot Number | NGCZ2257 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |