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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY 3M¿ ATTEST¿; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

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3M COMPANY 3M¿ ATTEST¿; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS Back to Search Results
Model Number 1243RE
Device Problem Problem with Sterilization (1596)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2021
Event Type  malfunction  
Event Description
Trauma instrument tray was placed in sterilizer with integrator tab which did not turn and therefore instrument tray was not considered sterile for use.There was concern for faulty integrator tabs.Manufacturer response for steam integrator tab, steam chemical integrator (per site reporter).Equipment failure reported to 3m.
 
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Brand Name
3M¿ ATTEST¿
Type of Device
INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
Manufacturer (Section D)
3M COMPANY
3m center,2510 conway ave.
bldg. 275-5w-06
st. paul MN 55144
MDR Report Key13357708
MDR Text Key284449025
Report Number13357708
Device Sequence Number1
Product Code JOJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/24/2022,01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1243RE
Device Catalogue Number1243RE
Device Lot NumberSG092023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2022
Event Location Hospital
Date Report to Manufacturer01/26/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/26/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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