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

Catalog Number 10144

Device Problem Device Handling Problem (3265)

Patient Problem Skin Burning Sensation (4540)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

The hcw was re-trained to always wear personal protective equipment (ppe) when working with sterrad® units and handling cassettes.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 Description

A customer reported a healthcare worker (hcw) received a "chemical burn" or skin reaction when removing two sterilization loads from a sterrad® 100nx unit and handling a new sterrad® 100nx cassette.The hcw was not wearing gloves, and it is unclear if the hydrogen peroxide skin reaction was related to handling the two sterilization loads or from the new cassette, but she developed white ¿patches¿ and felt a stinging sensation on her hands.She washed her hands and reported ¿it was a lot better.¿ the skin reaction on her hands/palms lasted one day, and she did not receive medical treatment.Lastly, it was noted her status was ¿good.¿ this event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the batch record review could not be completed as the lot number was unknown.Retains testing was not completed as the lot number was unknown.Product evaluation was not completed as the suspect product was not available.Trending analysis could not be completed as the lot number was unknown.The sra indicates the risk for exposure to toxic or corrosive material is "low." the most likely assignable cause of this issue was failure to follow the instructions for use (ifu) in wearing the appropriate personal protective equipment when handling sterrad® 100nx cassettes.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Type of Device: 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: 12640114
• MDR Text Key: 276677724
• Report Number: 2084725-2021-00371
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female