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

Catalog Number 14324

Device Problem Chemical Problem (2893)

Patient Problem No Information (3190)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® chemical indicator strip.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14100, lot number - the correct lot number is 189411-02.

Event Description

The customer reported a sterrad chemical indicator strip did not change color correctly after a completed sterrad 100s cycle.It is unknown if the affected load was recalled or released for use.It is unknown if there was any injury.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.(b)(4) are related complaints from the same facility.This is one of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2015-00469 and 2084725-2015-00470.

Manufacturer Narrative

Method: actual device not evaluated.Result: no results available since no evaluation performed.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, and system risk analysis (sra).Per the supplier's certificate of conformance all process specifications were met before release of product.Trending analysis by lot number was reviewed from 04/12/2015 to 10/09/2015 and trending was not exceeded.The sra indicates the risk associated with a quality problem with no impact to safety is "low." the product was not returned; therefore, no visual analysis was performed.The cause could not be verified.The customer suggested that sometimes heavier loads are ran at the facility which could be the cause of the issue however this cannot be definitively concluded.It is unlikely that the issue was with the unit as cycle completed and other indicators were changing properly.However, the customer stated all three of their sterrad® 100s units were experiencing the same issue.The customer was unresponsive to asp's attempts to obtain additional information.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
• MDR Report Key: 5166620
• MDR Text Key: 28908421
• Report Number: 2084725-2015-00469
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2015

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 Expiration Date: 01/31/2016
• 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: 10/05/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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