MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other,user facili report with the FDA on 2020-02-10 for NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER AND LOPEZ VALVE? 0056160 manufactured by C.r. Bard, Inc. (covington) -1018233.
[182799731]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[182799732]
It was reported that the diameter of the connection on the ng tube is small which makes decompression of the stomach more difficult. The customer noted that the patient was in the hospital for small bowel obstruction and had a ng tube in for decompression. The patient was very nauseated for several hours, unrelieved by medication and the ng tube was bringing back up some gastric content but not a lot. The provider reportedly hand irrigated the ng tube very forcefully with at least 2 syringes of water and after the second syringe, the ng tube dumped out 750ml of gastric contents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00924 |
| MDR Report Key | 9688408 |
| Report Source | DISTRIBUTOR,OTHER,USER FACILI |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-02-10 |
| 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 | 3 |
| Brand Name | NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER AND LOPEZ VALVE? |
| Generic Name | NG TUBE |
| Product Code | FEG |
| Date Received | 2020-02-10 |
| Model Number | 0056160 |
| Catalog Number | 0056160 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-10 |