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 Burning Sensation (4540)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hcw was re-trained to always wear personal protective equipment (ppe) when working with sterrad® units and handling cassettes.Asp complaint ref #: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A customer reported a healthcare worker (hcw) received a "chemical burn" or skin reaction when removing two sterilization loads from a sterrad® 100nx unit and handling a new sterrad® 100nx cassette.The hcw was not wearing gloves, and it is unclear if the hydrogen peroxide skin reaction was related to handling the two sterilization loads or from the new cassette, but she developed white ¿patches¿ and felt a stinging sensation on her hands.She washed her hands and reported ¿it was a lot better.¿ the skin reaction on her hands/palms lasted one day, and she did not receive medical treatment.Lastly, it was noted her status was ¿good.¿ this event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
Asp investigation summary: the batch record review could not be completed as the lot number was unknown.Retains testing was not completed as the lot number was unknown.Product evaluation was not completed as the suspect product was not available.Trending analysis could not be completed as the lot number was unknown.The sra indicates the risk for exposure to toxic or corrosive material is "low." the most likely assignable cause of this issue was failure to follow the instructions for use (ifu) in wearing the appropriate personal protective equipment when handling sterrad® 100nx cassettes.The issue will continue to be tracked and trended.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: 12640114
• Report Number: 2084725-2021-00371
• Device Sequence Number: 3286128
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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
• Device Lot Number: N/A
• 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: 09/20/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 44 YR
• Patient Sex: Female