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)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

The correct brand name is sterrad® sealsure chemical indicator tape.The correct common device is indicator, chemical.The correct catalog number is 14202_90.

Event Description

A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle.It is unknown if the affected load was reprocessed or released for use on patients, however, there have been no reports 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

(b)(4).Correction: information provided by the customer indicates no load was affected because no load was involved in this cycle.Asp investigation summary: the investigation included a review of the device/batch history record review (dhr), trending analysis by lot number, visual analysis, retains analysis, concomitant product evaluation, and system risk analysis (sra).The dhr/batch record review concluded all process specifications were met before the release of the product.Trending analysis by lot number was reviewed from 10/07/2016 to 04/05/2017 and trending was not exceeded.Visual analysis was not performed as the product was not returned for evaluation since user error was determined to be the cause of the issue.Retains testing was not performed since user error was determined to be the cause of the reported issue.An evaluation of the concomitant sterrad® 100s was not performed since user error was determined to be the cause of the reported issue the sra indicates the risk associated with a quality problem with no impact on safety is "low." the assignable cause of the issue can be attributed to incorrect placement of the sealsure tape.The customer reported a portion of the chemical indicator (ci) tape was placed facing down on the sterrad® 100s unit rack.Technical support representative (tsr) educated the customer on proper chemical indicator tape placement and advised the customer to re-run another cycle and ensure the tape was fully exposed, not covered by overlapped tape, wrap or other load items.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: 6520923
• MDR Text Key: 73669784
• Report Number: 2084725-2017-00219
• 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: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2017
• Device Catalogue Number: 14324
• Device Lot Number: 28016
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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