MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD VELOCITY BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL

Catalog Number 43210

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Results codes: 3191-suspect positive bi, load not recalled if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: cmp (b)(4).

Event Description

A customer reported a positive result with a sterrad velocity¿ biological indicator (bi) after a completed sterrad® 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 velocity¿ biological indicators when the load has been released and used on patient(s) prior to reprocessing.

Manufacturer Narrative

The customer reported they used two bis in one cycle.One bi test result was positive and the other bi test result was negative; therefore, they released the load to patients.Asp complaint ref #: (b)(4).

Manufacturer Narrative

Twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.Asp complaint ref #: (b)(4).

Manufacturer Narrative

H3: asp investigation summary: 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 device history record (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 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." ¿ the single sterrad® velocity¿ bi was returned for visual inspection.The bi was observed as activated with a compressed cap and broken/shattered media ampoule.The sample was observed as a processed bi with residual purple medium in the vial.The reason for return was not confirmed through visual analysis.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 returned for visual analysis and the issue could not be confirmed.The customer was advised to follow their facility policies and procedures regarding the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD VELOCITY BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 11227566
• MDR Text Key: 229589564
• Report Number: 2084725-2021-00009
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 20705037049407
• UDI-Public: 20705037049407
• Combination Product (y/n): N
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2021
• Device Catalogue Number: 43210
• Device Lot Number: 2242019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/27/2021; 04/30/2021; 08/20/2021
• Supplement Dates FDA Received: 02/19/2021; 05/21/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1