MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for BARD? NASOGASTRIC SUMP TUBE AND PREVENT? FILTER AND LOPEZ VALVE? WITH ENFIT? EN0056160 manufactured by C.r. Bard, Inc. (covington) -1018233.
[140535245]
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
[140535246]
It was reported that the sump tubes with enfit connection had a smaller internal diameter than the tubes they had previously received. The nurses have stated that they were having a hard time getting adequate suction due to the smaller size and as a result the tubes were getting clogged when there were large food particles and/or pill particles in the gastric contents. This was a common occurrence in the emergency department and for patient's going emergently to the operating room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-01629 |
| MDR Report Key | 8467207 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-06-07 |
| Date Mfgr Received | 2019-05-22 |
| Date Added to Maude | 2019-03-29 |
| 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 AND PREVENT? FILTER AND LOPEZ VALVE? WITH ENFIT? |
| Generic Name | NG TUBE PREVENT & LOPEZ ENFIT |
| Product Code | FEG |
| Date Received | 2019-03-29 |
| Model Number | EN0056160 |
| Catalog Number | EN0056160 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-29 |