MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for SALEM SUMP 8888266122 manufactured by Cardinal Health, Inc..
[121036500]
Ng tube already placed in patient had the blue/white vent piece break in half twice. Ng tube blue section was able to be cut and replaced blue/white vent from a new package. The second time it broke, the clear tubing was able to be cut to place patient on low intermittent suction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7897237 |
| MDR Report Key | 7897237 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-09-06 |
| Report Date | 2018-09-19 |
| Date Reported to FDA | 2018-09-19 |
| Date Reported to Mfgr | 2018-09-21 |
| Date Added to Maude | 2018-09-21 |
| 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 |
| Generic Name | TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION |
| Product Code | FEG |
| Date Received | 2018-09-21 |
| Model Number | 8888266122 |
| Catalog Number | 8888266122 |
| Lot Number | 1733219064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-21 |