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	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a health care worker (hcw) had a skin reaction from discarding the sterrad® 100nx cassettes by removing the cassettes from the disposal collection box.The hcw experienced skin discoloration of ¿white spots¿ on the index fingers, left thumb, and her right palm.The hcw reported washing the affected areas with soap and water, and the skin discoloration on the left thumb resolved immediately, and the spots were ¿all gone¿ the following morning.It was reported the hcw was wearing gloves, but it was unknown if hydrogen peroxide contact was due to damage/defect on the gloves or from the h2o2 on the gloves during disposal.The hcw went to the emergency room and the h2o2 skin reaction was checked, but no treatment was given or required.The injuries were assessed to be minor since the h2o2 skin reaction resolved without medical treatment; however, this event is being reported as a malfunction report subsequent to a previous serious injury.
Additional Manufacturer Narrative
An asp representative provided onsite retraining as per the sterrad® 100nx user guide, under cassette handling: ¿warning! hydrogen peroxide may be present.Do not remove used cassettes from the cassette collection box.Dispose of the sealed cassette collection box according to local waste regulations.¿ batch review could not be conducted due to unknown lot number.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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
Asp investigation summary: batch record could not be reviewed since the suspect sterrad® 100nx cassette lot number was not available.Trending analysis could not be conducted since the suspect sterrad® 100nx cassette lot number was not available.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.In addition, the lot number was not available and use error associated with the event was identified; therefore, no supplier investigation was performed.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 used cassettes, which cautioned: ¿for safety reasons, you must use the cassette disposal box to dispose of cassettes.Never reuse a cassette disposal box.Once a cassette disposal box has been removed, a new cassette disposal box must be inserted.¿ 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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 15384879
• Report Number: 2084725-2022-00259
• Device Sequence Number: 5383713
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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