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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY; INDICATOR, BIOLOGICAL STERILIZATION PROCESS
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STERIS BIOLOGICAL OPERATIONS VERIFY; INDICATOR, BIOLOGICAL STERILIZATION PROCESS Back to Search Results
Model Number DUAL SPECIES
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2016
Event Type  malfunction  
Event Description
Control biological indicator did not turn positive after 24 hour incubation.The biological indicator used during immediate use steam sterilization was negative (as expected).The negative readout for the control biological indicator provided a false negative when it should have been positive.Repeated control with same lot number and different lot number.Different lot number turned positive as expected.The same lot number remained the same after 24 hours incubation.
 
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Brand Name
VERIFY
Type of Device
INDICATOR, BIOLOGICAL STERILIZATION PROCESS
Manufacturer (Section D)
STERIS BIOLOGICAL OPERATIONS
9325 pinecone dr.
mentor OH 44060
MDR Report Key6066283
MDR Text Key58736577
Report Number6066283
Device Sequence Number1
Product Code FRC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/13/2016
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 Operator Other
Device Expiration Date07/25/2017
Device Model NumberDUAL SPECIES
Device Catalogue NumberS3061
Device Lot Number170725
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/13/2016
Event Location Hospital
Date Report to Manufacturer10/13/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; NO OTHER THERAPIES
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