MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-07 for KENDALL ARGYLE SALME SUMP manufactured by Tyco Healthcare.
[2446772]
Salem sump tube inserted with no resistance. No air was heard when tested. Tube was removed and found to be broken. Broken piece not retrieved as pt expired form other problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023376 |
| MDR Report Key | 2366393 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-11-10 |
| Date Added to Maude | 2011-12-13 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL ARGYLE SALME SUMP |
| Generic Name | NASOGASTRIC TUBE |
| Product Code | BSS |
| Date Received | 2011-12-07 |
| Lot Number | 121 506 464 |
| ID Number | 00388882661305 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-07 |