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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A customer reported a positive result with a sterrad® velocity¿ biological indicator (bi) after a completed sterrad® 100s 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 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 prior to reprocessing.
Additional Manufacturer Narrative
Device available for return correction from no to yes.One suspect positive bi was received.The ci disc is yellow, the cap is not pressed down, the vial is not crushed, and there is some purple media in the vial along with moisture which will not confirm the suspected positive result.The reason for the return was not confirmed.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
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 dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.Trending analysis by lot number was reviewed from (b)(6) 2018 to (b)(6) 2018 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.In addition, twenty-five unused bis were received but were expired; therefore, testing was not performed.The customer indicated the chemical indicator (ci) changed correctly.The results of previous and subsequent bis were negative.The bi was placed on the bottom shelf at the back of the chamber which may have contributed to the suspect positive bi.Per the velocity instructions for use (ifu), it is recommended to place the bi at the front of the chamber, not the back as the customer did.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification, dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot.Also, no manufacturing anomalies were observed in the returned suspect bi that would contribute to a positive bi result.An issue with sterrad performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly.The assignable cause is likely due to user error since placement of the bi in the chamber was not per the ifu.A customer letter will be sent addressing the user error for the suspect positive bi as well as following hospital policy for instrument recall/quarantine.The issue will continue to be tracked and trended.(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: 7601176
• Report Number: 2084725-2018-00634
• Device Sequence Number: 19349545
• Product Code: FRC
• UDI-Device Identifier: 10705037048908
• UDI-Public: 10705037048908
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2018

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: 10/08/2018
• Device Catalogue Number: 43210
• Device Lot Number: 0081802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 11/15/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 09/11/2018; 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1