MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER 0046180 manufactured by C.r. Bard, Inc. (covington) -1018233.
[137735711]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[137735712]
It was reported that the ng tube leaked from the indented tube portion where the blue air vent connects to the sump tube. The complainant noted that the device was placed in situ prior to the leak. The complainant also noted that the tube was originally used for decompression, and later for enteral feeds (promote at 20ml/hr) and meds (aspirin, lipitor, plavix, senokot, multivitamin liquid, thiamine, coreg, amiodarone, pepcid, lisinopril).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-00961 |
| MDR Report Key | 8359770 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-05-16 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER |
| Generic Name | NG TUBE |
| Product Code | FEG |
| Date Received | 2019-02-21 |
| Returned To Mfg | 2019-02-22 |
| Model Number | 0046180 |
| Catalog Number | 0046180 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |