MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for T.S. III ATS READY CDU 8884713176 manufactured by Covidien.
[118876057]
The tubing was bent or crimped, not allowing suction and the tube would not stay open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611018-2018-00300 |
| MDR Report Key | 7827952 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2018-08-10 |
| Date Added to Maude | 2018-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | SRAGH INDUSTRIAL ESTATE, CO, T |
| Manufacturer City | OFFALY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T.S. III ATS READY CDU |
| Generic Name | CHEST DRAINAGE KIT |
| Product Code | PAD |
| Date Received | 2018-08-29 |
| Model Number | 8884713176 |
| Catalog Number | 8884713176 |
| Lot Number | 16F097FHX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | SRAGH INDUSTRIAL ESTATE, CO, T OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |