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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD CYCLESURE; INDICATOR, BIOLOGICAL STERILIZATION PROCESS
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ADVANCED STERILIZATION PRODUCTS STERRAD CYCLESURE; INDICATOR, BIOLOGICAL STERILIZATION PROCESS Back to Search Results
Catalog Number 14324
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Information (3190)
Event Date 01/21/2014
Event Type  malfunction  
Event Description
We were contacted by our local advanced sterilization products (asp) sales representative.Asp manufactures biologicals for our sterrad sterilizers.We were told that due to supply constraints we may temporarily experience shipping delays for cyclesure 24 biological indicators (bi) over the next 3-4 weeks.The manufacturer understands this would affect our operations and are notifying us in advance to allow us to plan accordingly for this potential situation.How can we plan for this and still follow the manufacturer's indications for use (ifu)? the only way we can plan is try to reduce the number of sterilizer loads.
 
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Brand Name
STERRAD CYCLESURE
Type of Device
INDICATOR, BIOLOGICAL STERILIZATION PROCESS
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine CA 92618
MDR Report Key3608145
MDR Text Key4066310
Report Number3608145
Device Sequence Number1
Product Code FRC
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 01/27/2014
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 Invalid Data
Device Catalogue Number14324
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/27/2014
Event Location Other
Date Report to Manufacturer02/05/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/27/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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