MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX CASSETTE; STERRAD® 100NX STERILIZER

Catalog Number	10144
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a health care worker (hcw) experienced a skin reaction described as white marks on the hands when handling a new sterrad® 100nx cassette.It was reported that the leak indicator was ¿discolored,¿ and the hcw handled the cassette without wearing gloves.The affected areas were washed with water, and the symptoms resolved without requiring medical treatment.The h2o2 skin reaction was assessed to be a minor injury since it resolved without medical intervention; however, this event is being reported as a malfunction report subsequent to a previous serious injury.
Additional Manufacturer Narrative
E1.Initial reporter phone number: (b)(6).The hcw was re-trained to always wear appropriate personal protective equipment (ppe) when working with sterrad systems and cassettes.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the batch record, trending analysis by lot number, system risk analysis (sra), retains testing, and photo analysis.The batch history record was reviewed and no issues relating to the failure mode were noted.The involved batch met manufacturer specifications at the time of release.Retains testing was completed with no issues identified; the retain samples were within specifications.Trending analysis by lot number was reviewed from the manufactured date to the event date, and no significant trend was observed.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the suspect sterrad® 100nx cassette was not returned for evaluation.The assignable cause for the cassette leak could not be verified.The supplier product investigation did not reveal any anomalies related to this failure mode; all manufacturing in-process controls corresponded to specifications.Visual inspection of provided field sample picture shows an indicator bar with a discoloration to red on the edges.Red discoloration can be confirmed with h2o2 leakage as the most likely cause but cannot be determined from the image alone.No indication for a potential manufacturing related issue based on retain inspection and batch record review.The most likely assignable cause for the skin reaction can be attributed to user error for not wearing gloves and not following the warnings as per the sterrad® 100nx cassette instructions for use: ¿use personal protective equipment (e.G.Chemical resistant gloves) at all times when handling cassettes.¿ ¿warning: do not open the protective plastic wrapper if the leak indicator strip indicates a leak.If a leak is indicated, then the cassette might have been damaged.¿ asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Common Device Name: STERRAD® 100NX STERILIZER
• 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: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 17673867
• Report Number: 2084725-2023-00242
• Device Sequence Number: 20427738
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K071345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: 12/30/2023
• Device Catalogue Number: 10144
• Device Lot Number: 22L031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown