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 12/28/2015

Event Type  malfunction  

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 a review of the device batch record, lot trending, and system risk analysis (sra).The batch record was reviewed by the supplier.Several leaking cellblocks were detected during manufacturing.Corrective measures were taken after investigation; trending analysis by lot number was reviewed from 08/20/2015 to 12/28/2015 and trending was not exceeded; the sra indicates the risk associated with improper handling of a cassette is "low." the issue has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe).The chemical indicator on the cassette had changed to red indicating hydrogen peroxide exposure.The customer was advised to check the color of the chemical indicator and to wear ppe when handling cassettes.The issue will continue to be tracked and trended.

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 a burn on the right thumb.The affected area turned white and was washed with running water.The hcw did not receive any medical attention/treatment and the thumb healed in four hours.This event is being reported as a malfunction report subsequent to a serious injury.

• 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: 5391096
• MDR Text Key: 36849931
• Report Number: 2084725-2016-00025
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2015

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: 08/14/2016
• Device Catalogue Number: 10144
• Device Lot Number: 15H067
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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