MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE® 24 BIOLOGICAL INDICATOR

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2017

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® nx cycle.The chemical indicator (ci) changed color from red to bronze.Two subsequent bis were negative.The affected load was released and used on patient(s).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 when the affected loads have not been reprocessed.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and 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 by lot number was reviewed from (b)(6) 2017 to (b)(6) 2017 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the suspect bi was not returned for further analysis.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause could not be verified.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 chemical indicator disc changed correctly.The customer stated subsequent bi was negative for growth.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine 92618 ; 9497893837
• MDR Report Key: 7051475
• MDR Text Key: 93247299
• Report Number: 2084725-2017-00660
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 20705037016218
• UDI-Public: (01)20705037016218(17)180731(10)25117261
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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 Expiration Date: 07/31/2018
• Device Catalogue Number: 14324
• Device Lot Number: 25117261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 06/26/2018
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1