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

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® nx cycle.The chemical indicator (ci) changed color correctly.The subsequent bi result was negative.The affected load was reprocessed.There was 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 positive cyclesure® 24 biological indicators.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included a review of the device history record (dhr), trending of the product malfunction code, trending of lot number, system risk analysis (sra), and product retains analysis.The dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.Trending analysis for the product code of 'suspected positive bi" was reviewed from august 2014 through february 2015 and revealed a significant trend which was addressed through capa.Trending analysis by lot number was reviewed from 08/15/2015 to 11/13/2015 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the suspect positive cyclesure® bi was not returned for evaluation.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.Also, no damage or leakage was observed with the retains after processing.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification, dhr review found no anomalies that would contribute to a positive bi result, and lot history review found trending was not exceeded in this lot.An issue with sterrad® performance is also unlikely as the cycle passed and the customer stated subsequent bis were negative for growth.The cyclesure® retains met functional specification.As a result, there is not an issue with product performance when used per the instructions for use (ifu).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: 5291610
• MDR Text Key: 33943277
• Report Number: 2084725-2015-00562
• 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: 11/13/2015

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
• Device Lot Number: 22715264
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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