MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® CHEMICAL INDICATOR STRIP; INDICATOR, CHEMICAL

Catalog Number	14100
Medical Device Problem Codes	Chemical Problem (2893); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported a sterrad® chemical indicator strip did not change color correctly after a completed sterrad® 100nx express cycle and indicated this happened on eight different cycles/loads.All loads were recalled except one which was released and used on one patient.The ci strips were placed inside aesculap trays and there was no overlapping inside the tray.The ci strips are kept in the original bottle and stored in another room.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 load has been released without reprocessing first.
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis by lot number, retains testing, system risk analysis (sra) and concomitant product evaluation.Per the supplier, no anomalies were observed that would contribute to the customer's experienced issue.All process test specifications were met before release of the product.Trending analysis by lot number was reviewed for the previous six months from open date and trending was not exceeded.Thirty (30) retains ci¿s were subject to functional evaluation.All thirty (30) ci¿s changed color correctly after sterrad® sterilization processing.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the product was not returned; the customer stated the product was discarded.The concomitant sterrad® 100nx sterilizer was evaluated and tested by an asp field service engineer.The unit was in working condition and no maintenance was required.The assignable cause of the issue cannot be verified since the retains samples met specification, the impacted ci strips were not returned for evaluation, dhr met specifications before release, trending analysis by lot number did not reveal any significant trend and no problem could be found with the sterrad sterilizer.Indicator color variation, however, can be due to load placement in the chamber.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
The customer stated upon follow-up that they continue to have an issue intermittently with their ci strips changing color correctly.The issue is occurring with both asp ci strips and non-asp ci strips.It was also stated some strips were not from advanced sterilization products (asp).Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® CHEMICAL INDICATOR STRIP
• Common Device Name: INDICATOR, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8299535
• Report Number: 2084725-2019-00818
• Device Sequence Number: 13988545
• Product Code: FRC
• UDI-Device Identifier: 10705037016198
• UDI-Public: 10705037016198
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: 122331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 14100
• Device Lot Number: 121811-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/27/2019; 07/02/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 03/19/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERRAD® 100NX STERILIZER, SERIAL #: (B)(6)