MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for COVIDIEN KANGAROO NASOGRASTRIC FEEDING TUBE manufactured by Covidien.
[113447185]
Dobbhoff stylet naso-gastric tube inserted with positive color change on co2 detector. Inserted to 60 cm. Noted draining straw colored fluid. Chest xray showed tube in lung. A second tube was placed and chest xray showed a right pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078269 |
| MDR Report Key | 7665746 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-06-14 |
| Date Added to Maude | 2018-07-06 |
| 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 | 0 |
| Brand Name | COVIDIEN KANGAROO NASOGRASTRIC FEEDING TUBE |
| Generic Name | NASOGRASTRIC FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2018-07-05 |
| Lot Number | 180960018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Brand Name | COVIDIEN KANGAROO NASOGRASTRIC FEEDING TUBE |
| Generic Name | NASOGRASTRIC FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2018-07-05 |
| Lot Number | 180680311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-05 |