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	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a positive result with a sterrad velocity¿ biological indicator (bi) after a completed sterrad® cycle.It was initially reported that no load was involved.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.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).(b)(4).The customer provided lot numbers 0272104 and 0692106 but was unable to confirm which lot number was associated with this event.Advanced sterilization products will continue to follow up for additional information.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Additional information was received confirming the affected biological indicator (bi) lot number is 0272104, and that it was unknown if the load was released and used on a patient.There was no reported issue with lot number 0692106.The batch history record was reviewed and no issues relating to the failure mode were noted.The involved lot met manufacturer specifications at the time of release.Twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.Asp complaint ref #: cmp(b)(4).
Additional Manufacturer Narrative
Correction: block h6: type of investigation was reported in error and has been updated from testing of device from same lot/batch returned from user (4101) to testing of device from same lot/batch retained by manufacturer (11).H3: asp investigation summary: the investigation included a review of the device batch record, retains testing of lot, trending analysis by lot number, and system risk analysis (sra).Trending analysis by lot number was reviewed for the six months prior to 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 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 not returned so no further analysis could be performed.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
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 12756329
• Report Number: 2084725-2021-00420
• Device Sequence Number: 4326637
• Product Code: FRC
• UDI-Device Identifier: 20705037048905
• UDI-Public: 20705037048905
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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: 10/27/2021
• Device Catalogue Number: 43210
• Device Lot Number: 0272104
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/10/2021; 01/05/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/06/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown