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

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/22/2018

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 color correctly.The previous and subsequent bi results were both negative.The affected load was released and used on a patient(s).It is unclear at this time if there is any report of infection, injury or harm to patient(s) associated with this issue.Asp will continue to follow-up for additional information.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 load has not been reprocessed prior to release for use.

Manufacturer Narrative

Upon further follow-up with the customer, the load was used on four patients.However, it was confirmed there is no report of infection, injury or harm to patient(s) associated with the issue.(b)(4).

Manufacturer Narrative

Correction from follow-up report on 9/13/2018.It was incorrectly stated.Upon further follow-up with the customer, the load was used on four patients.However, it was confirmed there is no report of infection, injury or harm to patient(s) associated with the issue.It was later confirmed that four instruments were used on four patients.The four instruments were from two different bis, same lot, different loads.It is unknown which instruments were from which load.A 2nd complaint was opened for the 2nd suspect bi and is reported under asp complaint ref #: (b)(4) and manufacturer report number: 2084725-2018-00712.Device evaluated by mfr: 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 05/29/2018 to 08/22/2018 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 not returned for visual inspection.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.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 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.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® 24 BIO INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7875045
• MDR Text Key: 120242270
• Report Number: 2084725-2018-00713
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• 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
• Report Date: 08/22/2018

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: 04/30/2019
• Device Catalogue Number: 14324
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 08/22/2018
• Supplement Dates FDA Received: 10/10/2018; 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD 100S STERILIZER, SERIAL #: (B)(4)