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

Catalog Number	10144
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Discoloration (2074)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone number: (b)(4).Multiple attempts were made to obtain additional information; however, no further event details were received.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).
Event or Problem Description
A customer reported a health care worker (hcw) came in contact with hydrogen peroxide while inserting a new sterrad® 100nx cassette without wearing gloves.The hcw experienced skin reactions described as itchiness and white skin discoloration on two fingers.It was reported the hcw went to the emergency room; however, it is unknown whether medical intervention was received.Based on the information available at the time of this report, the h2o2 skin reaction was assessed to be minor injury; however, this event is being reported as a malfunction report subsequent to a previous serious injury.
Additional Manufacturer Narrative
Asp investigation summary: the batch history record could not be reviewed due to unknown lot number.Trending analysis could not be conducted due to unknown lot number.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the involved sterrad® 100nx cassette was not returned and the lot number is unknown; therefore, no further product evaluation or supplier investigation can be completed.The most likely assignable cause for the skin reaction can be attributed to user not following the sterrad® 100nx user guide for proper handling of cassettes.The customer was retrained to always wear appropriate personal protective equipment (ppe) when working with the sterilizer as per the sterrad® 100nx user guide: - ¿as a precaution, when handling any part of the system or load items that have been exposed to hydrogen peroxide, please wear the appropriate ppe (chemical resistant latex, pvc/vinyl, or nitrile gloves).¿ 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: 18387007
• Report Number: 2084725-2023-00320
• Device Sequence Number: 2674816
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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 Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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