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

Catalog Number	43210
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	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).Medical device problem code (b)(4).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 issues were observed in the release record that would contribute to the complaint.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 associated with exposure to biohazardous, pathogenic or infectious material is "low." the single sterrad velocity" bi was not returned for evaluation, and therefore, visual analysis could not be performed.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.However, the product was not returned so no further analysis could be performed.The customer was advised to follow their facility policies and procedures regarding the released load.The issue will continue to be tracked and trended.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported a positive result with a sterrad velocity" biological indicator (bi) after a completed sterrad¿ nx cycle.It was initially reported that the affected load, which included a cystoscope, was reprocessed.On (b)(6) 2021, advanced sterilization products (asp) received additional information that the 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.

• 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: 12145720
• Report Number: 2084725-2021-00227
• Device Sequence Number: 4259235
• Product Code: FRC
• UDI-Device Identifier: 20705037048905
• UDI-Public: 20705037048905
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: 09/14/2021
• Device Catalogue Number: 43210
• Device Lot Number: 3492031
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1