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

Catalog Number 14324

Device Problems Shelf Life Exceeded (1567); Appropriate Term/Code Not Available (3191)

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

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

The correct brand name is sterrad® chemical indicator strip.The correct common device is indicator, chemical.Catalog number - the correct catalog number is 14100, lot number - the correct lot number is 034511-01, expiration date ¿ the correct expiration date is 08/31/2016.(b)(4).

Event Description

A customer reported using expired sterrad chemical indicator in sterrad nx cycles for almost a month.The customer confirmed loads, cyclesure 24 biological indicators, sterrad sealsure chemical indicator tape and the expired strips have been passing.The affected loads were released.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 cases where a customer uses expired sterrad chemical indicator strips and the load is not recalled.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the certificate of conformance (c of c), trending of lot number, failure mode and effects analysis (fmea), and system risk analysis (sra).The c of c was reviewed and the involved batch met fda quality systems regulation, iso 13485 and manufacturer specifications at the time of release.Trending analysis by lot number was reviewed from 03/30/2016 to 09/26/2016 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the product was not required for return as there is sufficient evidence to indicate user error.There is no allegation of a functional issue with the ci strips.The customer stated the expired strips, loads, cyclesure biologicals and sterrad sealsure tape was passing.The customer was advised to utilize non-expired ci strips and the expired ci strips were discarded.The lot trending analysis results were trending not exceeded.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: 6042776
• MDR Text Key: 57925548
• Report Number: 2084725-2016-00618
• 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: 09/26/2016

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 Catalogue Number: 14324
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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