MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for COVIDIEN-CURITY UNK manufactured by Covidien.
[77423494]
Reported to risk management on may 18, 2017. Hole in thoracentesis catheter during the course of the procedure. Air entered the pt and may have contributed to a pneumothorax. The catheter and tray were not sequestered leading to limited info in this report. Reported to vendor/mfr by (b)(4) in materials management at (b)(6). Dose: needle aspiration, frequency: once, route used: pleural space. Diagnosis or reason for use: pleural effusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6633862 |
| MDR Report Key | 6633862 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-05-14 |
| Date Facility Aware | 2017-05-18 |
| Report Date | 2017-06-02 |
| Date Reported to FDA | 2017-06-02 |
| Date Reported to Mfgr | 2017-06-01 |
| Date Added to Maude | 2017-06-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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-CURITY |
| Generic Name | THORACENTESIS TRAY WITH SAFETY COMPONENTS |
| Product Code | PAD |
| Date Received | 2017-06-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | 5016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Brand Name | COVIDIEN-CURITY |
| Generic Name | THORACENTESIS TRAY WITH SAFETY COMPONENTS |
| Product Code | GAA |
| Date Received | 2017-06-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | 5016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-06-02 |