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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD; INDICATOR, BIOLOGIC STERILAZATION
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ADVANCED STERILIZATION PRODUCTS STERRAD; INDICATOR, BIOLOGIC STERILAZATION Back to Search Results
Catalog Number 14100
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 01/11/2014
Event Type  malfunction  
Event Description
Changes in external chemical indicators change color so staff can accept or reject sterile or compromised items.Staff rely on this visualization (change in colors), however lack of uniformity and standardization could result in using non-sterile equipment.Please refer to attached pictures.For example, steam tape before sterilization shows yellow lines.After sterilization, yellow lines turn brown.However sterrad tape before sterilization shows red letters.After sterilization, the letters are barely visible.The sterrad chemical indicator strip is red before sterilization, but yellow after sterilization.
 
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Brand Name
STERRAD
Type of Device
INDICATOR, BIOLOGIC STERILAZATION
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology dr
irvine CA 92618
MDR Report Key4131207
MDR Text Key15325883
Report Number4131207
Device Sequence Number1
Product Code FRC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/22/2014
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 Number14100
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/22/2014
Event Location Hospital
Date Report to Manufacturer10/01/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/22/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
YES, BUT NOT APPLICABLE
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