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

Catalog Number 14324

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100nx cycle.The bi was incubated for 12 hours.The chemical indicator (ci) changed color correctly.The previous and subsequent bi results were both 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.(b)(4).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.No retains testing was not performed as the lot has expired.It is unlikely the suspected positive bi was caused by a manufacturing issue since dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded.An issue with sterrad® performance is also unlikely as the cycle passed and the customer stated subsequent bis were negative for growth.Insufficient information is available to determine the assignable cause.The suspect bi was not returned and could not be evaluated for user error.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: 5404821
• MDR Text Key: 37740657
• Report Number: 2084725-2016-00028
• 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: 01/07/2016

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: 02/29/2016
• Device Catalogue Number: 14324
• Device Lot Number: 25815281
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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