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

Catalog Number 10144

Device Problem Chemical Problem (2893)

Patient Problem Skin Irritation (2076)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide while touching a used cassette from a sterrad® 100nx.The hcw was not wearing personal protective equipment (ppe) and experienced irritation/burn on both her palms.The hcw received an uknown burn cream treatment in the hospital.According to the report there were "no further complications and the worker currently is well and back to work." this event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Ni.

Manufacturer Narrative

Lot #: correction from unk to 15d002.Exp date: correction from na to 3/26/2016.Asp investigation summary: the investigation included a review of the batch history record (bhr), trending of lot number, system risk analysis (sra) and visual analysis.The dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.Trending analysis by lot number was reviewed from 01/08/2015 to 07/07/2015 and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." a visual inspection of the cassette identified the sleeve of the cassette was found to be open¿specifically, it was torn along one end of the cassette.Upon inspection of the individual peroxide cells, none exhibited any obvious signs of puncturing, like damage to the plastic cell housing.It should be noted that there may have been puncturing in the plastic creases separating each cell, but nothing visually identifiable.Additionally, seven of the cells were completely empty, while three cells were full.Apart from the corrosion of the label, there were no visible signs of damage to the cassette itself.The assignable cause of the issue could not be determined.Visual analysis of the returned product noted that upon inspection of the individual peroxide cells, none exhibited any obvious signs of puncturing, yet, 7 of the 10 cells were confirmed to be empty.The cassette was not tested for functionality in a sterrad unit due to the confirmed leakage.The supplier's batch record review found no anomalies that would contribute to the issue, and lot history review did not exceed trending for this lot.A customer letter and a copy of the instructions for use (ifu) were sent to the customer instructing them to always wear personal protective equipment when handling a used cassette.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 CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618
• MDR Report Key: 4960685
• MDR Text Key: 16493357
• Report Number: 2084725-2015-00172
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2015

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: 03/26/2016
• Device Catalogue Number: 10144
• Other Device ID Number: 10144
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 08/03/2015
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 08/30/2017
• Date Device Manufactured: 04/01/2015
• 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