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 Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2014

Event Type  malfunction  

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.After sterilization the chemical indicator (ci) changed color correctly.The load included 16 small dental instruments, 1 eco probe, and 2 laryngoscopes.The load was partially released and used on patients before the results were confirmed.The load item released was one eco probe.There was no injury or harm associated with the issue.This event is reported to the fda since the load was partially released and used on a patient(s) before the cyclesure® 24 biological indicator (bi) results were confirmed.

Manufacturer Narrative

Load not recalled and suspected positive bi.

Manufacturer Narrative

Manufacture date 08/24/2014.Asp investigation summary: the investigation included a review of the device history record, trending of the product malfunction codes and lot number, failure mode and effects analysis, and health hazard evaluation.¿ 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.¿ trending analysis for the product code of 'suspected positive bi" was reviewed from december 2013 through november 2014.The risk is categorized as "low." ¿ trending analysis for the product code of ''load not recalled" was reviewed from december 2013 through november 2014.All values are within the control limits.¿ trending analysis by lot number was reviewed from 08/24/2014 to 12/05/2014.There was no significant trend observed.¿ the fmea was reviewed and indicates the rpn associated for the failure mode is at an acceptable level.¿ the hhe was reviewed for the risk of using instruments from a load with a positive bi result which leaves a potential risk of the load not being successfully sterilized, thus could potentially transfer pathogens to patients.Each sterilization cycle is also monitored with physical parameters and chemical indicators.For the general population, the body¿s defense mechanisms make the chance for any organisms to establish into the body and cause infection to be relatively rare, especially factoring in the frequent use of prophylactic antibiotics prior to surgery.If a patient were to become infected, medical intervention would be required to resolve the infection.It is unlikely for an infection to occur; however, should it occur it could be significant for patients at greater risk.The product malfunction code of "load not recalled" was added because the customer did not successfully recall all items in the load.It is not related to a functional failure of the product.Further investigation into this issue is not required since the code is used for medwatch reporting purposes.Thirty-two (32) retains bis were subject to functional evaluation.All thirty-two bis met functional specification.Also, no damage or leakage was observed with the retains.The single cyclesure® 24 bi was returned for visual inspection.The chemical indicator disc was gold in color which indicates exposure to hydrogen peroxide.The crushed vial¿s media was yellow.No manufacturing related anomalies observed.Eleven (11) unused bis were returned for functional evaluation with two used as controls.Nine (9) bis met functional specification.Also, no damage or leakage was observed.It is unlikely the suspected positive bi was caused by a performance issue as the retains met functional specification, dhr review found no anomalies that would contribute to a positive bi result, and lot history review found no significant trend in this lot.Visual inspection revealed no manufacturing anomalies in the returned bi.Sterrad® performance is also unlikely as the cycle passed.The severity of the suspected positive bi was defined as ¿negligible.¿ tracking and trending data has not identified a trend that requires investigation.As a result, root cause evaluation will not be performed.The cyclesure® retains met functional specification.As a result, there is not an issue with product performance when used per the ifu.A customer letter has been sent addressing the ¿load not recalled.¿ 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
• MDR Report Key: 4371547
• MDR Text Key: 5112040
• Report Number: 2084725-2014-00407
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

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 Catalogue Number: 14324
• Device Lot Number: 23714087
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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