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

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported a (b)(6) 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 affected load was released and used on a patient prior to reprocessing.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 if the load has not been reprocessed prior to release for use on patient(s).

Manufacturer Narrative

Device available for evaluation.Device evaluated by manufacturer.Asp complaint ref #: (b)(4).

Manufacturer Narrative

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 unused returns testing.¿ 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 4/09/2018 to 07/06/2018 and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ one (1) used suspected positive bi was received.The ci disc is gold, the cap is depressed, the vial is crushed, and there is no media but yellow stain was in the vial with which to confirm the suspected positive result.The bi was disassembled, the following was found: one tyvek liner, glass ampoule shards, and one spore disc.There are no punctures on the plastic vial or tyvek® liner that would be consistent with false positive from external contamination.Though the suspect positive bi is confirmed, it cannot be verified as there was missing label for lot information.No manufacturing related anomalies observed.¿ thirty-two unused returned 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 unused returns product 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 previous and subsequent bi¿s were negative.The customer was advised to follow their facility procedures regarding reprocessing loads.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
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7736978
• MDR Text Key: 115647720
• Report Number: 2084725-2018-00667
• 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: 07/09/2018

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: 03/31/2019
• Device Catalogue Number: 14324
• Device Lot Number: 11818044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 09/06/2018; 01/14/2019
• Supplement Dates FDA Received: 10/02/2018; 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD 100S STERILIZER, SERIAL # (B)(4)