MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for MONOFLO ANTIREFLUX W/SPLGD NDLESS SAMPLING 6308 manufactured by Covidien.
[63518080]
Submit date: 12/22/2016. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[63518081]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a urine drain bag. The customer states that the connection with the balloon from the phycon catheter and the drain bag was loose and became detached from the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2016-00842 |
| MDR Report Key | 6198314 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-12-09 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2016-12-22 |
| 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 | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONOFLO ANTIREFLUX W/SPLGD NDLESS SAMPLING |
| Generic Name | URINE DRAIN BAG |
| Product Code | EXG |
| Date Received | 2016-12-22 |
| Model Number | 6308 |
| Catalog Number | 6308 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-22 |