MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL (FRC)

Catalog Number 14324

Device Problems Shelf Life Exceeded (1567); Chemical Problem (2893)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® sealsure chemical indicator tape.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14202.Lot number - the correct lot number is 32214.Expiration date: 09/2016.

Event Description

"a customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® cycle.The load was not released for use.There is no report of infection, injury or harm to patient(s) associated with this issue.It was determined the customer was using expired ci tape and was advised to discard the product and to always check the expiration date prior to use.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of sterrad® sealsure chemical indicator tape not changing color correctly.".

Manufacturer Narrative

The dhr review, trending analysis by lot number, visual analysis and retains testing was not performed since there is sufficient information to determine user error was the cause of the issue.The sra indicates the risk associated with a quality problem with no impact on safety is "low." no product was returned for analysis.The assignable cause of the issue can be attributed to user error.It was determined that the customer was using expired product.The customer was advised to discard the expired product and to always use non-expired product.The issue will continue to be tracked and trended.

• Brand Name: STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6385776
• MDR Text Key: 69329309
• Report Number: 2084725-2017-00118
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

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: Health Professional
• Device Catalogue Number: 14324
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1