MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for DRAINAGE BAG DBAG600 manufactured by Argon Medical Devices, Inc..
[128462411]
Argon drainage bags lot # 11227515 leaking from blue nozzle when attached to patient. Our nurse went through four from this same lot number and none of the nozzles close properly. She finally found some with a different lot number that worked. Manufacturer response for drainage bag, argon medical devices (per site reporter). Left message. No response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8105550 |
| MDR Report Key | 8105550 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-17 |
| Report Date | 2018-11-09 |
| Date Reported to FDA | 2018-11-09 |
| Date Reported to Mfgr | 2018-11-27 |
| Date Added to Maude | 2018-11-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | DRAINAGE BAG |
| Generic Name | BAG, BILE COLLECTING |
| Product Code | EXF |
| Date Received | 2018-11-27 |
| Model Number | DBAG600 |
| Catalog Number | DBAG600 |
| Lot Number | 11227517 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-11-27 |