MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-25 for SKATER CENTESIS CATHETER * manufactured by Argon Medical Devices, Inc..
[20015695]
Physician and ultrasound (us) tech were performing a thoracentesis procedure when the hub of the catheter broke off. The physician removed catheter and placed a larger one and continued to drain the fluid. After the procedure, a chest x-ray revealed a pneumothorax and the patient was monitored and additional chest x-ray was taken. The pneumothorax reduced in size and a chest tube was not needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3970026 |
| MDR Report Key | 3970026 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-04-11 |
| Report Date | 2014-07-25 |
| Date Reported to FDA | 2014-07-25 |
| Date Reported to Mfgr | 2014-07-31 |
| Date Added to Maude | 2014-07-31 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER CENTESIS CATHETER |
| Generic Name | CATHETER, CONTINUOUS IRRIGATION |
| Product Code | GBQ |
| Date Received | 2014-07-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 1062271 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | 1445 FLAT CREEK RD. ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-25 |