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

Catalog Number 10144

Device Problems Chemical Spillage (2894); Device Handling Problem (3265)

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

The batch record review did not reveal any indication on a deviating quality profile for this batch.No events or deviations were reported.All in-process controls corresponded to the specification.(b)(4).

Event Description

A customer reported a healthcare worker (hcw) received a peroxide burn to their finger while removing the packaging from a sterrad® 100nx cassette that appeared to be leaking.The healthcare worker was not wearing gloves.The hcw rinsed the affected area with water, then was seen in the emergency room where an ointment was applied.The symptoms lasted approximately one week and is reported to be doing ¿good.¿ the hcw did not miss any work due to this event.There are no serious injuries reported with this event; however, this event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the batch record, lot trending, and system risk analysis (sra).Trending analysis by lot number was reviewed from 02/23/2017 to 08/22/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the sterrad® 100nx cassette was not returned for functional testing.There is insufficient information to determine an assignable cause of the leaking cassette/indicator not changing correctly (remaining white) as the customer did not return the product for further evaluation.The issue of human contact with h202 is due to user error.The hcw was not wearing personal protective equipment (ppe) while handling the cassette.The customer was re-trained on proper handling of cassettes and advised to always follow the instructions for use (ifu).The issue will continue to be tracked and trended.

• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6857059
• MDR Text Key: 85805534
• Report Number: 2084725-2017-00561
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2017

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 Expiration Date: 03/22/2018
• Device Catalogue Number: 10144
• Device Lot Number: 17C044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 01/11/2018; 01/12/2018
• Supplement Dates FDA Received: 01/11/2018; 01/12/2018
• Date Device Manufactured: 03/27/2017
• 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