MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-09-12 for STERI-GAS 4-100 manufactured by 3m Co..
[15379924]
A hospital employee claimed ethylene oxide gas cartridge was leaking before it was installed in sterilizer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2000-00011 |
| MDR Report Key | 296273 |
| Report Source | 05,06 |
| Date Received | 2000-09-12 |
| Date of Report | 2000-07-24 |
| Date Mfgr Received | 2000-05-11 |
| Date Added to Maude | 2000-09-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GAIL STEWARD |
| Manufacturer Street | 3M CENTER BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517369057 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-GAS 4-100 |
| Generic Name | EO-GAS CARTRIDGE |
| Product Code | FLI |
| Date Received | 2000-09-12 |
| Model Number | NA |
| Catalog Number | 4-100 |
| Lot Number | DEC 99 021 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 286777 |
| Manufacturer | 3M CO. |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 PO BOX 33275 ST. PAUL MN 551333275 US |
| Baseline Brand Name | STERI-GAS |
| Baseline Generic Name | EO GAS CATRIDGE |
| Baseline Model No | NA |
| Baseline Catalog No | 4-100 |
| Baseline ID | * |
| Baseline Device Family | STERILIZATION HARDWARE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-09-12 |