MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for SALEM SUMP DUAL LUMEN STOMACH TUBE,ANTI-REFLUX VALVE 8888266122 manufactured by Cardinal Health 200, Llc.
[185517817]
The anti-reflux valve used to plug the end of the ng tube was found to be broke in half. Gi contents were leaking from the end of the ng due to this equipment malfunction. A new anti-relux valve was ordered to replace the broken valve. The equipment was a 14fr ng salem pump dual lumen stomach tube by covidien. In this particular situation, the patient was on comfort cares/hospice and it was determined it would cause the patient too much distress to remove the device and replace it. Instead, we used a replacement anti-reflux valve to cap the tube when not in use to prevent further leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897156 |
| MDR Report Key | 9897156 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Report Date | 2020-03-25 |
| Date Reported to FDA | 2020-03-25 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | SALEM SUMP DUAL LUMEN STOMACH TUBE,ANTI-REFLUX VALVE |
| Generic Name | TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION |
| Product Code | FEG |
| Date Received | 2020-03-30 |
| Model Number | 8888266122 |
| Catalog Number | 8888266122 |
| Lot Number | 1831018364 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |