MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® VELOCITY¿ BI; INDICATOR, BIOLOGICAL (FRC)

Catalog Number	43210
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A customer reported a positive result with a sterrad® velocity¿ 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 sterrad® velocity¿ biological indicators when the loads have been released for use prior to reprocessing.
Additional Manufacturer Narrative
Concomitant med products correction from sterrad sterilizer to sterrad® nx sterilizer, serial #: (b)(4).Additional information received by the customer during follow up: the bi was incubated for 30 minutes.The chemical indicator (ci) changed color correctly.The two subsequent bi results were both positive.Asp complaint ref #: (b)(4).
Additional 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 05/05/2018 to 08/30/2018 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the sterrad® velocity bi was not returned for visual inspection.Twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.Upon follow-up, the customer stated they were unable to provide any further details regarding the event.The assignable cause could not be verified.It is unlikely the suspected positive bi was caused by a performance 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.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: STERRAD® VELOCITY¿ BI
• Common Device Name: INDICATOR, BIOLOGICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7871260
• Report Number: 2084725-2018-00706
• Device Sequence Number: 1720147
• Product Code: FRC
• UDI-Device Identifier: 10705037048908
• UDI-Public: 10705037048908
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K994055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 43210
• Device Lot Number: 1251827
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 01/09/2019; 02/12/2019
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 01/21/2019; 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERRAD STERILIZER; STERRAD® NX STERILIZER, SERIAL #: (B)(4)