MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for 15FR WOUND DRAIN TUBE BARD SILICONE, ROUND, FULL FLUTED, 4 CHANNEL DRAIN 072228 manufactured by C.r. Bard, Inc..
[183272307]
During chest tube removal, when pulled, a "snap! " could be heard. The tube broke apart and a portion of the tube remained inside the patient's chest. Another provider was needed to remove the retained piece of chest tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9829083 |
| MDR Report Key | 9829083 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-26 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-13 |
| Date Added to Maude | 2020-03-13 |
| 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 | 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 | 15FR WOUND DRAIN TUBE BARD SILICONE, ROUND, FULL FLUTED, 4 CHANNEL DRAIN |
| Generic Name | CATHETER, IRRIGATION |
| Product Code | GBX |
| Date Received | 2020-03-13 |
| Catalog Number | 072228 |
| Lot Number | 192212 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| 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 | 2020-03-13 |