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

Catalog Number 10144

Device Problem Use of Device Problem (1670)

Patient Problems Skin Discoloration (2074); Skin Burning Sensation (4540)

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

The hcw was re-trained to always wear appropriate personal protective equipment (ppe) when working with sterrad systems.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 Description

A customer reported a female health care worker (hcw) experienced a skin reaction of burning/tingling sensation and discoloration on the hands when replacing an ejected sterrad® 100nx cassette from the unit.It was reported no damage or leak was observed for the new cassette, and the hcw handled the cassettes without wearing gloves.The affected areas were immediately washed with water, and the symptoms resolved within two hours without requiring medical treatment.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

Asp investigation summary: 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 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 hcw was retrained to always wear appropriate personal protective equipment (ppe) when working with sterrad systems.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: 16556965
• MDR Text Key: 311738597
• Report Number: 2084725-2023-00059
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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