MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE® BIO INDICATOR; INDICATOR, BIOLOGICAL

Catalog Number	14324
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	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: sterrad sterilizer, serial # unknown.(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
A customer reported a positive result with a cyclesure® 24 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 cyclesure® 24 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 device history record (dhr), system risk analysis (sra), visual analysis, functional analysis of unused bis and retains analysis.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." visual analysis was performed on the photograph provided by the affiliate.Two vials with yellow media are shown.The ci disc of one vial is red, while the ci disc of the second vial is gold.The reported issue was confirmed.Thirty-four (34) unused cyclesure® bis were returned for functional evaluation.Functional specification was met with 0+/32 bis (the two additional bis were used as positive and negative controls).Thirty-two (32) cyclesure® bis were subject to functional evaluation.Functional specification was met with all bis.The concomitant sterrad serial number was not available and it is unknown if the sterrad was evaluated as no further information is available.The assignable cause can not be verified.The complaint product was not returned for evaluation; however, the customer provided a photograph of the bi and the reported issue was confirmed.Additionally, 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 unused returned product met functional specifications.The customer will be sent a letter to address the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CYCLESURE® BIO INDICATOR
• Common Device Name: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 9199738
• Report Number: 2084725-2019-00962
• Device Sequence Number: 448025
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• Combination Product (Y/N): N
• PMA/510(K) Number: K994055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 10/30/2019
• Device Catalogue Number: 14324
• Device Lot Number: 33018101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1