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	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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® cycle.The load was released for use before the bi result was determined.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
Correction: missing information in the initial report for block h10: ¿the batch history record was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.¿ the biological indicator (bi) was returned and visually inspected.The single returned sample was observed processed with a yellow ci disc.The sample had been activated (crushed) with a depressed cap, shattered ampoule, and residual media in the bottom of the vial.Writing was observed on the ci disc.The reason for return is not confirmed by visual analysis.Twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the batch record, trending analysis of the lot number, retains and product testing, and system risk analysis (sra).Trending analysis of the lot number for the sterrad® velocity biological indicator (bi) was reviewed for the prior six months from open date and no significant trend was observed.Review of risk documentation shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." upon review of the sterrad® velocity reader log data, it was found that a use error occurred.The sterrad® velocity bi was not properly activated causing the reported issue to occur.The assignable cause of the suspected positive bi is likely due to use error as asp recommended product instructions were not followed.According to the sterrad® velocity¿ instructions for use (ifu): precautions: make sure the growth medium fills the growth reservoir, and there are no large bubbles present.The customer was educated regarding the user error and 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: 12836900
• Report Number: 2084725-2021-00405
• Device Sequence Number: 20071168
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2022

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: 05/05/2022
• Device Catalogue Number: 43210-30-14
• Device Lot Number: 2172103
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 04/06/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 12/17/2021; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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