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

Catalog Number 14324

Device Problems Shelf Life Exceeded (1567); Chemical Problem (2893)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® sealsure chemical indicator tape.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14202.Lot number - the correct lot number is 11213-a.Expiration date - the correct expiration date is 02/28/2015.

Event Description

A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle.The customer stated the expiration date of the product was 02/2015 and was instructed since the product was expired, it should no longer be used.The customer stated the inventory will be checked and expired product will be discarded.The affected load was not released.There is 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 sterrad® sealsure chemical indicator tape not changing color correctly.

Manufacturer Narrative

Asp investigation summary: the investigation included trending of lot number and system risk analysis (sra).Trending analysis by lot number for product codes 'expired product' and 'color-chemical indicator' was reviewed six months prior to complaint open date (11/18/2015 to 05/16/2016); trending has not been exceeded for either issue.The sra indicates the risk associated with hazard of 'quality problem with no impact on safety' is "low." the suspect device was not available for product analysis as it was discarded by the customer.Review of the instructions for use (ifu 107101-03), section 'precaution,' indicates "do not use after expiration date." the customer was advised not to use the product after expiration date.

• 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: 5696334
• MDR Text Key: 46468595
• Report Number: 2084725-2016-00330
• 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: 05/16/2016

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: 05/16/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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