MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for 10FR SILICONE ROUND DRAIN 0070210 manufactured by C.r. Bard, Inc..
[138100177]
The drain was surgically placed and removed postoperatively at bedside. During removal resistance was met and the drain tubing snapped out of the insertion site. X-ray was obtained and a small piece of the catheter tubing was found to have been retained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8398831 |
| MDR Report Key | 8398831 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-01-21 |
| Date of Event | 2019-01-09 |
| Report Date | 2019-01-21 |
| Date Reported to FDA | 2019-01-21 |
| Date Reported to Mfgr | 2019-03-07 |
| Date Added to Maude | 2019-03-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 10FR SILICONE ROUND DRAIN |
| Generic Name | CONNECTOR, CATHETER |
| Product Code | GCD |
| Date Received | 2019-03-07 |
| Model Number | 0070210 |
| Catalog Number | 0070210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-07 |