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 03/13/2015

Event Type  malfunction  

Event Description

An international facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide from touching a new sterrad® 100nx cassette while inserting it into the unit.The hcw was not wearing personal protective equipment (ppe) and experienced tingling and noticed a white patch (blanching) on the end of one finger approximately 10mm wide.The hcw flushed the affected area with water and did not seek or receive any medical attention.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Device available for evaluation: no.Device evaluated by manufacturer: not returned.Device manufacture date: 10/2014.Supplier batch review: per the supplier, there was an issue in production which lead to 100% vacuum testing of the cellblocks.Further investigation without the field sample is not possible.

Manufacturer Narrative

Method: no testing methods performed; result: no results available since no evaluation performed; conclusion: failure to follow instructions.Asp investigation summary: the investigation included supplier product evaluation, lot trending, and system risk analysis (sra).The suspect product was not available for return for testing; trending analysis by lot number was reviewed from 09/18/2014 to 03/12/2015 and trending was not exceeded; the sra indicates the risk associated with improper handling of a cassette is "low." the reported cassette leakage could not be confirmed as the product was not available for evaluation.The instructions for use (ifu) of the sterrad® 100nx cassette state: "use personal protective equipment (e.G.Chemical resistant gloves) at all times when handling cassettes." a customer letter was sent advising the customer to wear proper ppe to avoid this issue in the future.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: 4614663
• MDR Text Key: 18920638
• Report Number: 2084725-2015-00060
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 03/13/2015

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: 10/17/2015
• Device Catalogue Number: 10144
• Device Lot Number: 14J086
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2015; 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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