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	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The healthcare worker was advised to wear gloves when handling any part of the sterrad system or load items that have been exposed to h2o2, including cassettes.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported a healthcare worker (hcw) received a skin reaction while opening the packaging of a sterrad® 100nx cassette and noticed liquid on the cassette.The healthcare worker was not wearing gloves.The symptoms included white spots on both hands and the hcw immediately washed them with water.The symptoms lasted approximately four and a half hours.The hcw did not seek or receive any medical attention/treatment and is reported to be "okay." this event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending analysis by lot number, concomitant product evaluation, and system risk analysis (sra).The device batch record was not reviewed as the lot number of the cassette was not available.Supplier product evaluation was not performed as the cause of the reported issue is user error.Lot trending was not performed as the lot number was not available.The concomitant sterrad sterilizer was re-booted with the customer over the phone and the issue was resolved.The sra indicates the risk associated with improper handling of a cassette is "low." the issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).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
• MDR Report Key: 11676154
• Report Number: 2084725-2021-00114
• Device Sequence Number: 11512860
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: UNAVAILABLE
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1