MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD VELOCITY BI; INDICATOR, BIOLOGICAL

Catalog Number	43210-30-14
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).(b)(4).
Event or Problem Description
A customer reported a suspect positive result with a sterrad velocity¿ biological indicator (bi) after a completed sterrad® cycle.They stated two bis were used and one bi negative and one bi was positive.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 load has been released and used on patient(s) prior to reprocessing.
Additional Manufacturer Narrative
H3: 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 device history record (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 bi manufacture date to complaint open date and trending was not exceeded.¿ review of risk documentation shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." ¿ the single sterrad® velocity¿ bi was returned for visual inspection.The bi was observed as activated with a compressed cap and broken/shattered media ampoule.The sample was observed as a processed bi with residual purple medium in the vial.The reason for return was not confirmed through visual analysis.¿ twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.The assignable cause of the issue could not be verified.The dhr review found no anomalies that would contribute to the complaint issue and retains testing met specification.Additionally, the product was returned for visual analysis and the issue could not be confirmed.The customer was advised to follow their facility policies and procedures regarding the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD VELOCITY BI
• Common Device Name: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 11629672
• Report Number: 2084725-2021-00098
• Device Sequence Number: 3015636
• Product Code: FRC
• UDI-Device Identifier: 20705037049407
• UDI-Public: 20705037049407
• Combination Product (Y/N): N
• PMA/510(K) Number: K994055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 06/10/2021
• Device Catalogue Number: 43210-30-14
• Device Lot Number: 2542011
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1