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 Codes	Skin Discoloration (2074); Skin Burning Sensation (4540)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information reported that the hcw was removing the used cassette from the sterrad® sterilizer collection box in order to reuse the container.An asp representative provided onsite retraining as per the sterrad® 100nx user guide, under cassette handling: ¿warning! hydrogen peroxide may be present.Do not remove used cassettes from the cassette collection box.Dispose of the sealed cassette collection box according to local waste regulations.¿ asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported a healthcare worker (hcw) had an h2o2 skin reaction after removing a sterrad® 100nx cassette from the sterrad® sterilizer collection box.The hcw experienced pain in the fingertips and the skin turned white.The affected area was washed with running water, and the skin reaction lasted one day.The hcw did not receive medical treatment and was reported as ¿fully recovered¿.The hcw was wearing gloves at the time of the event; however, the h2o2 skin contact occurred when the hcw removed the gloves for disposal.The injuries were assessed to be minor since the h2o2 skin reaction resolved without medical treatment; however, the skin reaction was due to contact with h2o2 from a sterrad® 100nx cassette; therefore, this event is being reported as a malfunction subsequent to a serious injury.
Additional Manufacturer Narrative
Additional event information provided the lot number for the suspect medical device.Asp investigation summary: the investigation included a review of the batch history record, trending analysis by lot number, and system risk analysis (sra).¿ the batch history record was reviewed and no non-conformances were reported at the time of product release; manufacturer specifications were met.¿ trending analysis by lot number was reviewed for the six months prior to open 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 had been discarded.In addition, product evaluation and supplier investigation were not performed as this event has been determined to be user error.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, which cautioned against removing used cassettes from the collection box as hydrogen peroxide may be present.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: 14626866
• Report Number: 2084725-2022-00158
• Device Sequence Number: 4588449
• 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): 07/15/2022

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: 11/28/2022
• Device Catalogue Number: 10144
• Device Lot Number: 21K023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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