MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-09-05 for 3M STERI-GAS EO CARTRIDGES 8-170 manufactured by 3m Healthcare.
[18278461]
A 3m technical service engineer received info from a medical facility that two employees reported symptoms following a possible ethylene oxide (eo) exposure. The facility reported that one employee had a cough and the other employee was diagnosed with aspermia. The symptoms reported have many possible causes. The customer reported they discovered two empty and one half-filled cartridges. There were no eo alarms because the eo monitor was near the eo sterilizer and the cartridges were far from the monitor. Photos of the cartridges show there was a definite dent in the rim that was likely the cause of the high emit rate.
Patient Sequence No: 1, Text Type: D, B5
[18521994]
Pt info was not available. No other adverse pt effects were reported. If add'l info is received, a follow-up report will be submitted. No eval will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2012-00032 |
| MDR Report Key | 2743201 |
| Report Source | 06,07 |
| Date Received | 2012-09-05 |
| Date of Report | 2012-07-30 |
| Date of Event | 2012-07-30 |
| Date Mfgr Received | 2012-07-30 |
| Date Added to Maude | 2012-09-14 |
| 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 | BALCHEM |
| Manufacturer Street | 95 BALCHEM LANE |
| Manufacturer City | GREEN POND SC 29446544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29446 5443 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-GAS EO CARTRIDGES |
| Generic Name | ACCESSORY TO M.D., NOT REGULATED BY FDA |
| Product Code | FLI |
| Date Received | 2012-09-05 |
| Model Number | NA |
| Catalog Number | 8-170 |
| Lot Number | 201606AJ |
| ID Number | UPC: 50707387394344 |
| 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 HEALTHCARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-05 |