MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-01-20 for 3M STERI-VAC STERILIZER/AERATOR 5XL 5XLP manufactured by 3m Health Care.
[15883588]
There were two units that were placed on each other. One upper and one lower. The upper unit was reported to be on accelerated mode and had a serial number of (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15930778]
It was reported that a male employee within the hospital sterilization facility was exposed to eo when a female operator of the 3m eo sterilizer opened the door prior to full aeration after being informed to abort cycle. It was reported the sterilizer was on accelerated mode when the event occurred. The accelerated mode should not have been used for a standard sterilization process for this mode is only applicable when unit is being serviced. User error contributed to this event. The male employee sought medical consultation at the occupational health clinic within the hospital. It was reported that the employee experienced a headache. At this time, it is not known whether any medical intervention was administered for the hospital would not release this info. The estimated exposure time to the operator was 15 to 30 seconds. There was another individual (female operator of sterilizer) and this subject was reported under 2110898-2014-00003. This report includes more info concerning the actual event and service info. This report only covers the male subject regarding his exposure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2014-00004 |
| MDR Report Key | 3608905 |
| Report Source | 06,07 |
| Date Received | 2014-01-20 |
| Date of Report | 2013-12-24 |
| Date of Event | 2013-12-24 |
| Date Mfgr Received | 2013-12-24 |
| Device Manufacturer Date | 1994-07-01 |
| Date Added to Maude | 2014-02-06 |
| 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 | LINDA JOHNSEN |
| Manufacturer Street | INFECTION PREVENTION DIVISION |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-VAC STERILIZER/AERATOR 5XL |
| Generic Name | ETHYLENE OXIDE GAS STERILIZER |
| Product Code | FLF |
| Date Received | 2014-01-20 |
| Model Number | 5XL |
| Catalog Number | 5XLP |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE. ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-20 |