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

Model Number	14324
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).(b)(4).
Event or Problem Description
A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® cycle.The affected load was released and used on a patient.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 load has been released and used on patient(s) prior to reprocessing.
Additional Manufacturer Narrative
Concomitant med products: sterrad 100nx sterilizer, serial # unk.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis 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 for the previous six months from open date and no further investigation or escalation is required at this time.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The single cyclesure® 24 bi was not returned for visual inspection.However, a photograph of the product was provided.The ci disc is yellow, the cap is depressed, and there is yellow media in the vial.The reported issue was confirmed.An issue with sterrad® performance is unlikely as the cycle passed and the chemical indicator disc changed correctly.The assignable cause can be attributed to user error as the customer reported that tape/labeling was placed over the cap holes prior to processing.There is no evidence to suggest an alleged deficiency since the dhr review found no anomalies that would contribute to a positive bi result, and retains product met functional specifications.As a result, there is not an issue with product performance when used per the instructions for use (ifu).The customer was sent a letter to address the user errors of releasing the load prior to reprocessing and placing tape/labeling over the cap holes.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
On 6/1/2020, asp became aware that information submitted for medwatch 2084725-2019-01000, follow-up: 2; on 6/1/2020 was incorrect.G4: date received by manufacturer: correction from 11/13/2019 to 5/18/2020.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Date of event correction from (b)(6) 2019 to (b)(6) 2019 asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE BIO INDICATOR
• Common Device Name: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 9399030
• Report Number: 2084725-2019-01000
• Device Sequence Number: 11425268
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K994055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 14324
• Device Catalogue Number: 14324
• Device Lot Number: 9919017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 02/24/2020; 11/13/2019; 06/01/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 03/17/2020; 06/01/2020; 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1