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

Catalog Number 10144

Device Problem Use of Device Problem (1670)

Patient Problem Skin Discoloration (2074)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

A customer reported a female health care worker (hcw) experienced ¿chemical burns¿ when she removed used sterrad® 100nx cassette from the collection box for disposal.It was reported the hcw was not wearing gloves.Her hand turned white, and she reported the reaction went away in a couple hours.The hcw washed the affected area and applied lotion, and reported she did not seek medical attention for the reaction.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.

Manufacturer Narrative

The customer provided lot number 23d032 and 23d011 but was unable to confirm which cassette lot number was involved in the minor skin reaction.The hcw was re-trained to always wear appropriate personal protective equipment (ppe) when working with sterrad systems and cassettes.As per the sterrad® 100nx user's guide: ¿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.¿ ¿use personal protective equipment (e.G.Chemical resistant gloves) at all times when handling 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).

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the trending analysis of the issue for the potentially affected lot numbers provided, and the system risk analysis (sra).Trending analysis of the issue for the potentially involved lot numbers was reviewed for the prior six months from 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 involved sterrad® 100nx cassette was discarded and not available for evaluation.Additionally, use error associated with the event was identified; therefore, no further investigation will be completed as use errors do not constitute a deficiency against the device.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 that hydrogen peroxide may be present and to not remove used cassettes from the collection box, and to always wear appropriate personal protective equipment when working with the sterilizer and handling cassettes.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Type of Device: 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: 18069416
• MDR Text Key: 327398244
• Report Number: 2084725-2023-00307
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1