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	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The batch history record was reviewed; no non-conformances were identified, and no anomalies were observed that would contribute to the reported issue.The reported lot number met manufacturer specifications at the time of release.Asp complaint ref #: cmp-(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.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 was 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 batch history record, trending analysis of the lot number, system risk analysis (sra), and retains testing.¿ 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." twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.The single sterrad velocity¿ bi was not returned for evaluation, and therefore, visual analysis could not be performed.The assignable cause of the suspected positive bi could not be verified.The batch history record 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.Asp will continue to track and trend this issue.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: 14274417
• Report Number: 2084725-2022-00113
• Device Sequence Number: 12239086
• Product Code: FRC
• UDI-Device Identifier: 20705037048905
• UDI-Public: 20705037048905
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 10/13/2022
• Device Catalogue Number: 43210
• Device Lot Number: 0132208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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