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 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

The correct catalog number is 14324-97, the correct lot number is 1826098.(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 24 hours.The chemical indicator (ci) changed color correctly.The subsequent bi result was negative.The affected load was recalled.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

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.

Manufacturer Narrative

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.Trending analysis by lot number was reviewed from 06/30/2016 to 12/06/2016 and trending was not exceeded.The sra indicates the risk associated with a quality problem with no impact on safety is "low." two vials received, one has a golden ci cap and the ci disc is golden in color, indicative of peroxide exposure.The cap is depressed with signs of strikes on the vial.The ampule inside is crushed into pieces and the vial is completely dry.The second vial ci disc is purple, no media, ampules has signs of strikes, and the ampule inside is intact.There is a single tyvek® liner and single spore disc present.There are no punctures on the outer vial or tyvek® liner that would be consistent with false positive from external contamination.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The likely assignable cause was due to user error.The customer stated there was reduced media observed in the vial after processing.Per the instructions for use (ifu), it is recommended to reprocess the load again with another bi.A customer letter will be sent regarding the proper use of the bi.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: 6211263
• MDR Text Key: 63486357
• Report Number: 2084725-2016-00796
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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: 06/30/2017
• Device Catalogue Number: 14324
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• 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; Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2017; 02/10/2017; 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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