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

Model Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

Manufacturer Narrative

Additional information was received from the affiliate that states the load from the suspected positive bi was not released for use on patients.Therefore, this file is no longer deemed reportable since there is no risk to patients.Asp complaint ref #: (b)(4).

Manufacturer Narrative

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).

• Brand Name: CYCLESURE® BIO INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 9366195
• MDR Text Key: 179506279
• Report Number: 2084725-2019-00997
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016211
• UDI-Public: 10705037016211
• Combination Product (y/n): N
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 14324
• Device Catalogue Number: 14324
• Device Lot Number: 10719018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 04/15/2020
• Supplement Dates FDA Received: 01/08/2020; 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1