MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06,07 report with the FDA on 2011-08-12 for 3M STERI-VAC 8XL STERILIZER/AERATOR manufactured by 3m Health Care.
[19874072]
3m rec'd info from a customer that reported during a chemdac monitoring cycle the alarm sounded. No one was in the room but an employee ran into the room and placed a badge on the 3m steri-vac 8xl sterilizer/aerator. Reportedly, the staff aerated until the next day and then entered the room with the sterilizer. It was reported they did not have an overexposure of ethylene oxide (eo) per (b)(4) limits, however, they did have an eo exposure when the employee put the badge on the machine. The badge read 7. 99 ppm in a 30 min sampling time but the person was not wearing the badge that entire time and there were no reported symptoms.
Patient Sequence No: 1, Text Type: D, B5
[19948740]
No other adverse pt effects were reported. If add'l info is rec'd, a f/u report will be submitted. No eval will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2011-00106 |
| MDR Report Key | 2218358 |
| Report Source | 04,06,07 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-07-16 |
| Date of Event | 2011-07-16 |
| Date Mfgr Received | 2011-07-16 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2011-08-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANDREA GRABANSKI |
| Manufacturer Street | 3M CENTER BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517331047 |
| Manufacturer G1 | 3M NEW ULM |
| Manufacturer Street | 1617 NORTH FRONT STREET |
| Manufacturer City | NEW ULM MN 56073 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56073 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-VAC 8XL STERILIZER/AERATOR |
| Generic Name | 880.6860 STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLF |
| Date Received | 2011-08-12 |
| Model Number | NA |
| Catalog Number | 8XL |
| Lot Number | 45078 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-12 |