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

Catalog Number 14100

Device Problems Chemical Problem (2893); Improper Chemical Reaction (2952)

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

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event 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.

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).

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
• Type of Device: INDICATOR, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8299535
• MDR Text Key: 134877236
• Report Number: 2084725-2019-00818
• 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: 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
• Device Operator: 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 Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 02/27/2019; 07/02/2019
• Supplement Dates FDA Received: 03/19/2019; 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD® 100NX STERILIZER, SERIAL #: (B)(6)