MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for SALEM SUMP 8888266130 manufactured by Covidien / Cardinal Health 200, Llc..
[180902003]
The anti reflux valve from the salem sump broke off and got stuck in the nasogastric tube. Two rns worked with hemostats to retrieve the valve; however, it crumbled into pieces as they tried to remove it. It appeared to be dry rotted. Eventually the rns was able to remove it from the ng tube completely without causing any pt harm. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093212 |
| MDR Report Key | 9744700 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-16 |
| Date Added to Maude | 2020-02-24 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | DUAL LUMEN TUBE FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION |
| Product Code | FEG |
| Date Received | 2020-02-21 |
| Catalog Number | 8888266130 |
| Lot Number | 1924101364 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN / CARDINAL HEALTH 200, LLC. |
| Manufacturer Address | MANSFIELD MA 08048 US 08048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |