3M(TM) STERI-VAC (TM) 8XL STERILIZER/AERATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-04 for 3M(TM) STERI-VAC (TM) 8XL STERILIZER/AERATOR manufactured by 3m Health Care.

Event Text Entries

[132207464] Device is under investigation. Initial analysis by service engineers indicates over-temperature condition. Components have been requested for additional analysis and root cause determination. The sterilizer was manufactured in year 2005. This mdr represents patient 2; emdr 2110898-2019-00002 represents patient 1. End of report.
Patient Sequence No: 1, Text Type: N, H10


[132207465] A (b)(6)-year-old female employee alleged that she experienced nasopharynx itching and an intense headache after a 3m? Steri-vac? 8xl sterilizer/aerator (serial number (b)(4)) chamber was opened and a 3m? Steri-gas ethylene oxide cartridge was found to be broken. The users at the hospital reported that the sterilized material and the inside of the chamber were very hot. The patient saw a nurse for the symptoms and no treatment was provided. The symptoms subsided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2110898-2019-00003
MDR Report Key8219483
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-04
Date of Report2019-03-28
Date of Event2018-12-06
Date Mfgr Received2018-12-06
Date Added to Maude2019-01-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DIANNE GIBBS
Manufacturer Street3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE
Manufacturer CityST. PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal55144
Manufacturer Phone6517379117
Manufacturer G13M COMPANY
Manufacturer Street1617 NORTH FRONT ST.
Manufacturer CityNEW ULM MN 56073
Manufacturer CountryUS
Manufacturer Postal Code56073
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M(TM) STERI-VAC (TM) 8XL STERILIZER/AERATOR
Generic NameSTERILIZER EO GAS
Product CodeFLF
Date Received2019-01-04
Returned To Mfg2019-02-07
Model Number8XL
Catalog Number8XL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-01-04

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