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

Catalog Number	10144
Health Effect - Clinical Codes	Skin Irritation (2076); Burning Sensation (2146)
Date of Event	12/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: serial sterrad® nx sterilizer, # 0033111057 asp complaint ref #: cmp-000029871 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 two healthcare workers (hcws) experienced a burn after touching a sterrad 100nx cassette which had been mistakenly inserted into a sterrad nx sterilizer.The hcws were not wearing personal protective equipment (gloves) at the time of the event and did not receive any medical attention/treatment.No steps were taken to resolve or treat the skin reaction, the symptoms disappeared the same day, and the hcws are now recovered.This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report number 2084725-2021-00006 for the first hcw.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, retains testing of lot, functional analysis, trending analysis by lot number, and system risk analysis (sra).Retains testing was not completed as the cause of the reported issue is user error.The cassette was not returned as the cause of the reported issue is user error.Trending analysis by lot number was reviewed for the six months prior to open date and trending was not exceeded.The sra indicates the risk for exposure to toxic or corrosive material is "low." the issue has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe) while handling the cassette.Customer re-training was provided by the asp sales representative and advised the customer to always wear gloves when handling cassettes and loads from the sterilizer.In addition, the customer was reminded to always check they are using the proper cassette prior to insertion into the unit.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
The batch record review did not indicate a deviating quality profile for this batch.No events or deviations were reported that could relate to this issue.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD 100 NX CASSETTE
• Common Device Name: STERRAD® 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 11168426
• Report Number: 2084725-2021-00007
• Device Sequence Number: 14273651
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• PMA/510(K) Number: K071345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2021

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 Expiration Date: 07/10/2021
• Device Catalogue Number: 10144
• Device Lot Number: 20G014
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/26/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 02/16/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/04/2021; 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1