MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL (FRC)

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2016

Event Type  malfunction  

Manufacturer Narrative

Catalog number - the correct catalog number is 14324-97.(b)(4).

Event Description

A customer reported a positive result with a cyclesure 24 biological indicator (bi) after a completed sterrad 100s cycle.The bi was incubated for 48 hours.The chemical indicator (ci) changed color correctly.The previous bi result was negative.The affected load was reprocessed.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.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis by lot number, visual analysis, retains analysis and system risk analysis (sra).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.A review of trending by lot number was not performed as the issue was determined to be user error.The suspect bi was not returned for visual inspection as the issue was determined to be user error.Retains testing was not performed as this issue was determined to be user error.The sra indicates the risk associated with a quality problem with no impact on safety is "low." the customer confirmed they covered the two holes on the bi prior to processing indicating user error caused the positive bi.Per the instructions for use (ifu), in order to enable the sterilant, hydrogen peroxide to get into the sterrad cyclesure 24 vial, do no not place tape or labels over the holes in the cap of the sterrad cyclesure 24 bi prior to processing.The instructions for use (ifu) was sent to the customer.The issue will continue to be tracked and trended.

• Brand Name: STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6211261
• MDR Text Key: 63483473
• Report Number: 2084725-2016-00797
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

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: 05/31/2017
• Device Catalogue Number: 14324
• Device Lot Number: 17916096
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1