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

Catalog Number 14324

Device Problems Chemical Problem (2893); Device Operates Differently Than Expected (2913); Environmental Particulates (2930)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

The correct brand name is sterrad® chemical indicator strip common device - the correct common device is indicator, chemical catalog number - the correct catalog number is 14100.

Event Description

A customer reported a sterrad® chemical indicator strip did not change color correctly after a completed sterrad® 100nx express cycle.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 sterrad® chemical indicator strips not changing color correctly.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, visual analysis, concomitant product evaluation and system risk analysis (sra).The device history record (dhr) for the lot was reviewed and met manufacturing specifications when released.No anomalies were observed that would contribute to the customer¿s experienced issue.Trending analysis by lot number was reviewed from 08/12/2016 to 02/08/2017 and trending was not exceeded.The sra indicates the risk associated with a quality problem with no impact on safety is "low." the product was not returned; therefore, no visual analysis was performed.An issue with the concomitant sterrad® nx is unlikely since the related biological indicator (bi) and the chemical indicator tape changed appropriately.Upon follow-up, the customer stated the color changed on the chemical indicator (ci) strip, but it was not as light as they are used to seeing.The technical services representative (tsr) sent the customer the chemical indicator comparator chart and it was determined to be within the acceptable parameters.Therefore, no problem was found with the issue.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: 6369015
• MDR Text Key: 68778733
• Report Number: 2084725-2017-00104
• 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: 02/09/2017

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
• Device Lot Number: 336511-03
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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