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 Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: it is unknown which of the two sterrad sterilizers the issue occurred.Sterrad nx sterilizer, serial # (b)(4) and sterrad 100s sterilizer, serial # (b)(4).(b)(4).Test specifications for product release were met.No issues were observed in the dhr that would contribute to the complaint.Asp complaint ref #: (b)(4).
Event or Problem Description
Upon follow-up for another issue, a customer reported a positive result with a sterrad® velocity¿ biological indicator (bi) after a completed sterrad® cycle.The unrelated issue occurred on three separate event dates: (b)(6) 2019 and the customer does not know which of the three event dates the suspect positive bi occurred.The chemical indicator (ci) changed color correctly.The previous and subsequent bi results were both negative.However; the bi was reported to have media evaporation in the vial after sterilization.The affected load was recalled except one item 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 velocity¿ biological indicators when the load has been released and used on patient(s) prior to reprocessing.
Additional Manufacturer Narrative
Upon follow-up, the customer indicated the chemical indicator (ci) cap changed color from red to pink and the growth medium was purple after incubation.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Manufacturer email correction from(b)(4).Manufacturing contact email correction from (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 and functional analysis and retains analysis.Trending analysis by lot number was reviewed for the previous six months from open date and trending was not exceeded.The sra indicates the risk associated with exposure to bio-hazardous, pathogenic or infectious material is "low." the single cyclesure® 24 bi was returned for visual inspection.The ci disc was yellow, the cap was pressed down, the vial was crushed and there was dried purple media in the vial.Media evaporation was confirmed.Fourteen unused bis were returned and subject to functional evaluation.Functional specification was met with 0+/12 bis (the two additional bis were used as positive and negative controls).Also, no damage or leakage was observed with the retains after processing.Thirty retains bis were subject to visual analysis.All thirty met specification and no breakage or leakage was observed with any of the 30 bis retains samples.Twenty-two retains bis were subject to functional evaluation and no physical damage, leakage or evaporation was observed after sterrad® processing.The assignable cause of the issue is likely due to user error as the customer reported the media in the vial had decreased after processing and the ci disc was not yellow.There is no evidence to suggest an alleged deficiency since the dhr review found no anomalies that would contribute to a positive bi result, retains product met functional specifications and lot history review did not show any significant trend.There is no evidence that the reported issue was related to the sterrad performance as the cycle passed and the previous and subsequent bis were negative for growth.A customer letter will be sent to address the user error and 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: 8817757
• Report Number: 2084725-2019-00910
• Device Sequence Number: 11472698
• Product Code: FRC
• UDI-Device Identifier: 10705037048908
• UDI-Public: 10705037048908
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K994055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2019

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: 11/15/2019
• Device Catalogue Number: 43210
• Device Lot Number: 0461915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 09/09/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/22/2019; 09/17/2019
• Patient Sequence Number: 1