MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-01 for SILICONE SALEM PUMP manufactured by .
[2175240]
The pt's nasal ft (silicone salem pump) clogged after administration of morning dose of lansoprazole odt via tube. Rn worked on it and was able to unclog the tube. About two hours later with another med administration (calcium citrate, mv w/ minerals), the tube was clogged and unable to unclog; nurse tried hot water and (b)(6). This report is consistent with multiple prior incidents in other pts at our institution of tube occlusion secondary to lansoprazole solu-tab administration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022100 |
| MDR Report Key | 2237973 |
| Date Received | 2011-09-01 |
| Date of Report | 2011-09-01 |
| Date of Event | 2011-08-21 |
| Date Added to Maude | 2011-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE SALEM PUMP |
| Generic Name | NASAL FT |
| Product Code | BSS |
| Date Received | 2011-09-01 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-01 |