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	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).The hcw was re-trained to always wear personal protective equipment (ppe) when handling cassettes.The batch record review did not reveal any indication on a deviating quality profile for this batch.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 "burn" or skin reaction when removing a sterrad® 100nx cassette from the collection box.The hcw was not wearing gloves and she made contact with hydrogen peroxide on her index finger.She washed with running water and treated the skin reaction with gentamicin ointment by her own self-judgment.She did not receive medical treatment, nor was she diagnosed by a physician.The skin reaction measured 2 cm and symptoms resolved the following day.Lastly, it was noted her status was ¿completely recovered.¿ 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 completed with no issues identified.All in-process controls are within specifications.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.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "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.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: 12375000
• Report Number: 2084725-2021-00294
• Device Sequence Number: 11746246
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 04/18/2022
• Device Catalogue Number: 10144
• Device Lot Number: 21D022
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR