MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-26 for BOC GASES * manufactured by Boc Gases.
[367507]
There was a sudden failure of an e-cyln of calibration gas (unopened). The cylinder had a high pressure leak at the point where the "post" enters the body of the tank. There was a small amount of rust in the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031374 |
| MDR Report Key | 515829 |
| Date Received | 2004-02-26 |
| Date of Report | 2004-02-19 |
| Date of Event | 2004-02-19 |
| Date Added to Maude | 2004-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOC GASES |
| Generic Name | ECYLINDER |
| Product Code | BXK |
| Date Received | 2004-02-26 |
| Returned To Mfg | 2004-02-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 970E12 |
| ID Number | ICC 3AA20154 |
| Device Expiration Date | 2009-01-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 504836 |
| Manufacturer | BOC GASES |
| Manufacturer Address | 4551 NORTH ACCESS ROAD CHATTANOOGA TN 37415 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-26 |