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

Catalog Number 14324

Device Problems Chemical Problem (2893); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

A customer reported the sterrad® chemical indicator strip did not change color correctly after a completed sterrad® cycle.The affected load was reprocessed.There is no report of infection, injury or harm to patient(s) associated with this issue.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® chemical indicator strip not changing color correctly.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the certificate of conformance, trending of lot number and system risk analysis (sra).Per the certificate of conformance, the involved lot met manufacturer specifications at the time of release.Trending analysis by lot number was reviewed from 06/04/2016 to 12/01/2016 and trending was not exceeded.The sra indicates the risk associated with hazard of 'quality problem with no impact on safety is "low." the product was not returned; therefore, no visual analysis was performed.An issue with sterrad® performance is also unlikely as the cycle passed and the subsequent ci strip and sealsure tape changed color correctly.There is insufficient information to determine an assignable cause.The customer was unresponsive to multiple attempts to obtain further 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 ; 9497893837
• MDR Report Key: 6207686
• MDR Text Key: 63371644
• Report Number: 2084725-2016-00789
• 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: 12/01/2016

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: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 14324
• Device Lot Number: 187611-02
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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