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

Catalog Number	10144-90
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).Asp will continue to follow up regarding this issue.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported that a healthcare worker (hcw) experienced a ¿burn¿ from a hydrogen peroxide skin contact when removing a used sterrad® 100nx cassette from the unit.The hcw was only wearing a glove on one hand, and the skin reaction occurred on the unprotected hand.The h2o2 skin reaction lasted one day, and there is no report of medical attention.Lastly, it was reported the hcw status was ¿painless remission¿.The information suggests the h2o2 skin reaction was not serious; however, this event is being reported as a malfunction report subsequent to a previous serious injury.
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the batch record, trending analysis by lot number, and system risk analysis (sra).¿the batch record was reviewed and no issues relating to the event were noted.The product met manufacturer specifications at the time of release.¿ trending analysis for the lot number was reviewed from the manufactured date to 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 used sterrad® 100nx cassette was discarded and not available for evaluation.In addition, use error was identified to have contributed to the adverse event; therefore, no further product evaluation or supplier investigation was conducted.The most likely assignable cause for the h2o2 skin reaction can be attributed to failure to follow the sterrad® 100nx user guide in handling used cassettes and wearing appropriate personal protective equipment.The customer was re-trained to always wear ppe when handling cassettes.Asp will continue to track and trend this issue.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: 13502191
• Report Number: 2084725-2022-00019
• Device Sequence Number: 14799412
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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 Expiration Date: 10/13/2022
• Device Catalogue Number: 10144-90
• Device Lot Number: 21J020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown