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

Model Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/12/2017

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® 100s cycle.The bi was incubated for 24 hours.The chemical indicator (ci) changed correctly.The affected load was not recalled for reprocessing.There was no report of infection, injury or harm to patient(s) associated with this issue.A subsequent bi result was negative.Asp will continue to follow up for additional information regarding the event.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 load is released without reprocessing.

Manufacturer Narrative

Additional information was received by the customer indicates the affected load was not released for use on patient(s).Based on the additional information provided by the customer, this event is no longer considered a reportable event.

Manufacturer Narrative

Additional information previously received indicates the affected load was not released for use on patient(s); however, it is unclear whether or not the load was recalled or reprocessed.As such, this complaint is deemed reportable.

Manufacturer Narrative

(b)(6).(b)(4).

Manufacturer Narrative

Device returned for evaluation correction from no to yes.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 05/20/2017 to 09/12/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the single cyclesure® 24 bi was returned for visual inspection.The chemical indicator disc was yellow in color which indicates exposure to hydrogen peroxide and the cap was pressed down.The tyvek liner was in place and the ampoule was broken in the crushed vial.There was no media remaining in the vial to confirm the issue.Observed.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.Also, no manufacturing anomalies were observed in the returned suspect bi that would contribute to a positive bi result.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 INDICATORS
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 6929816
• MDR Text Key: 89950457
• Report Number: 2084725-2017-00594
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: (01)10705037016211(17)180430(10)14017226
• Combination Product (y/n): N
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/12/2017

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: 04/30/2018
• Device Model Number: 14324
• Device Catalogue Number: 14324-97
• Device Lot Number: 14017226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 10/16/2017; 01/05/2018; 07/10/2018; 07/10/2018
• Supplement Dates FDA Received: 11/07/2017; 01/05/2018; 07/10/2018; 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1