MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CHEM INDICATOR STRIP CS; INDICATOR, CHEMICAL (FRC)

Catalog Number 14100

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Operates Differently Than Expected (2913)

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

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a sterrad® chemical indicator strip did not change color correctly after a completed sterrad® nx cycle.The customer stated there are "white spots" on the chemical indicator strip after the cycle completion.The affected load was released for use on patients prior to reprocessing.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 when the loads have not been reprocessed prior to release.

Manufacturer Narrative

Asp complaint ref #: (b)(4).

Manufacturer Narrative

Further information from the customer stated the ci strips were changing to the correct color but stated they seemed to be sticking to the plastic window of the tyvek peel packs.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), retains testing and supplier evaluation.Per the supplier, the batch record meets all specifications and was manufactured in accordance to advanced sterilization products quality requirements.Trending analysis by lot number was reviewed from 10/26/2017 to 04/26/2018 and trending was not exceeded.The sra indicates the risk associated with a quality problem with no impact on safety is "low." the reported product was not returned.However, the customer returned four boxes of unused product of the same lot.Testing was performed on 30 strips of the return product and the failure mode was not replicated as 30/30 passed with no discrepancies noted.Per the supplier, it is possible for the ci strip to stick to the clear side of the pouches if exposed to high moisture.In absence of moisture, if a device was placed between the ci strip and the pouch, and the device was a heat sink, metallic, a faster color change could occur in this area.Color change is dependent on localized concentration of hydrogen peroxide and localized temperature.This would be more evident if the pouch is turned tyvek side up, clear side down as the strip would be facing down towards the mylar/clear polyester side and an instrument might land on top.There shouldn¿t be a significant difference on whether the pouches ae turned one way or another excluding the heat sink issue described above.Diffusion/effusion and pure flux of hydrogen peroxide is far faster than the length of even a half cycle.Color change of the ci strip should not be impacted by position if unrestricted flow is allowed (up/or facing down).Further review by an asp subject matter expert revealed chemical indicator strips are allowed to contain some white spots as designed and indicated in the product specification.The assignable cause could not be confirmed but may be attributable to the customer misinterpreting the color of the strips as a few white dots are acceptable per the strip design.Additionally, the supplier reports there is a chance of restricted diffusion during the cycle or due to high moisture (device not thoroughly dried prior to sterilization) which may have been a contributor.The issue will continue to be tracked and trended.Product complaint #: (b)(4).

• Brand Name: CHEM INDICATOR STRIP CS
• Type of Device: INDICATOR, CHEMICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7538901
• MDR Text Key: 109110830
• Report Number: 2084725-2018-00614
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016198
• UDI-Public: 10705037016198
• Combination Product (y/n): N
• PMA/PMN Number: 122331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 14100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1