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 Code	Skin Discoloration (2074)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Cassettes with unused hydrogen peroxide are hazardous waste as defined by the us environmental protection agency and should be disposed of accordingly.If it is necessary to handle a used cassette, wear chemical resistant latex, pvc (vinyl), or nitrile gloves.Do not touch gloves to your face or eyes.¿ 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).
Event or Problem Description
A customer reported that a female health care worker (hcw) experienced a hydrogen peroxide burn when she handled a used sterrad® 100nx cassette that was not in the cassette collection box for disposal.The hcw did not wear gloves and suffered a white skin reaction/discoloration on her index finger.She removed the chemical with running water and did not receive medical treatment.The skin reaction was reported as lasting at least one day and was ¿getting better¿.The reported skin reaction has been determined to be a minor injury since there was no permanent damage or impairment, and no medical intervention was received.However; this event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
An asp clinical education consultant retrained the hcw to always wear appropriate personal protective equipment (ppe) as per the sterrad® 100nx user guide.Asp investigation summary: ¿ the batch record review could not be performed 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 has been discarded and not available for evaluation.In addition, no further product evaluation or supplier investigation was conducted as user error has been identified.The most likely assignable cause for the h2o2 skin reaction can be attributed to failure to follow the sterrad® 100nx user guide in handling used cassettes.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: 14775114
• Report Number: 2084725-2022-00192
• Device Sequence Number: 13786721
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/15/2022
• 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