MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for DRAINAGE BAG DBAG600H manufactured by Argon Medical Devices, Inc..
[98649740]
Patient Sequence No: 1, Text Type: N, H10
[98649741]
Received note from nursing floor, issues with the argon drainage bag, ref dbag600, lot 11110997, 600 ml, seals at both ends of the bag are leaking, product is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7230174 |
| MDR Report Key | 7230174 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-12-28 |
| Report Date | 2018-01-02 |
| Date Reported to FDA | 2018-01-02 |
| Date Reported to Mfgr | 2018-01-02 |
| Date Added to Maude | 2018-01-31 |
| 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 |
| 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 | 2018-01-31 |
| Model Number | DBAG600H |
| Catalog Number | DBAG600H |
| Lot Number | 11112308 AND 11110997 |
| Device Availability | * |
| 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 | 2018-01-31 |