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

Catalog Number 10144

Device Problem Use of Device Problem (1670)

Patient Problem Burning Sensation (2146)

Event Date 12/01/2021

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).

Event Description

A customer reported that a healthcare worker (hcw) experienced a ¿burn¿ from a hydrogen peroxide skin contact when removing a sterrad® 100nx cassette collection box from the unit.The hcw was not wearing gloves, and it is unclear if the hcw made direct contact with the sterrad® 100nx cassette itself.Multiple attempts were made to obtain additional information, but no further details were provided for this event.The limited 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.

Manufacturer Narrative

Asp investigation summary: retains testing was not conducted as the cause of the reported issue is user error.The cassette was not returned as the cause of the reported issue is user error.Trending analysis by lot number was not performed due to unknown lot number.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the assignable cause is attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe) while handling sterrad 100nx cassette and collection box.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: 13048499
• MDR Text Key: 282566785
• Report Number: 2084725-2021-00458
• Device Sequence Number: 1
• Product Code: MLR
• 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: 02/08/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1