MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for COVIDIEN 8817748001 manufactured by Covidien Lp.
[83626709]
Cardiopulmonary arrest immediately following insertion requiring intubation and mechanical ventilation. Echocardiogram showed air embolus. Neurological deficits. Unable to determine user error or defective product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071770 |
| MDR Report Key | 6816513 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-08-02 |
| Date Added to Maude | 2017-08-24 |
| 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 |
| 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 |
| Generic Name | PERMCATH |
| Product Code | KNZ |
| Date Received | 2017-08-24 |
| Model Number | 8817748001 |
| Catalog Number | 8817748001 |
| Lot Number | 1621600102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Deathisabilit | 2017-08-24 |