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

Catalog Number	10144
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a male health care worker (hcw) experienced a "h2o2 burn" when he removed a used sterrad® 100nx cassette from the collection box without gloves.The affected area on his hand turned white, but the skin reaction resolved, and he is reported "okay".He visited the doctor/clinician; however, it is it is unknown if medical treatment was received.The "h2o2 burn" 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
H3: asp investigation summary: the investigation included a review of the device batch record, trending analysis by lot number, and system risk analysis (sra).· batch record could not be reviewed since the suspect sterrad® 100nx cassette lot number was not provided.· trending analysis could not be conducted since the suspect sterrad® 100nx cassette lot number was not provided.· review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the suspect sterrad® 100nx cassette was discarded and not available for evaluation.Additionally, the lot number was not available and user error associated with the event was identified; therefore, no supplier investigation was performed.The issue has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe) while working with the sterrad® 100nx.The customer was re-trained to always wear ppe when working with the sterrad® 100nx, and to not remove used cassettes from the cassette collection box.Asp will continue to track and trend this issue.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).

• Brand Name: STERRAD® 100NX CASSETTE
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology dr.; irvine CA 92618
• Manufacturer Contact: mark ongkeko ; 33 technology dr.; irvine, CA 92618 ; 9495619452
• MDR Report Key: 19994101
• Report Number: 2084725-2024-00030
• Device Sequence Number: 8586002
• Product Code: MLR
• UDI-Device Identifier: 10705037014903
• UDI-Public: 10705037014903
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/15/2024
• 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: Male