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 Burning Sensation (4540)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
A customer reported a healthcare worker (hcw) received a "low temperature burn" or skin reaction when she opened a new package of sterrad® 100nx cassette.The hcw was not wearing gloves, and she made contact with hydrogen peroxide before noticing the h2o2 indicator strip changed color.She experienced tingling sensation on her fingers for both hands.She rinsed both hands with running water, and it was reported symptoms disappeared at a later time.No medical attention or treatment was received for the h2o2 skin reaction and it was reported she recovered.This event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
A visual analysis of field sample pictures was performed.The pictures showed an opened sterrad® 100nx cassette with the indicator bar changed from white to a dark red, and the cells of the cassette appear to be empty.Retain samples were visually inspected, and no signs of leakage through color change of the indicator bar was observed.Additionally, the rfid label check was performed and showed the correct variable data (product code, lot# and expiry date).Since the manufacturing record evaluation did not identify any deviations or non-conformances, it is highly unlikely that such a defect occurred during production or packaging.The report of color change and leakage was confirmed through field sample pictures; however, return of a physical field sample would be necessary to perform further analysis.Asp complaint ref #: cmp-(b)(4).
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
• 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: 12844583
• Report Number: 2084725-2021-00415
• Device Sequence Number: 4080894
• 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,Followup
• Report Date (Section B): 02/04/2022

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: 07/31/2022
• Device Catalogue Number: 10144-90
• Device Lot Number: 21H014
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 02/04/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/20/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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