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 11/17/2014

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 chemical burns on his hands.The hcw flushed his hands with water for 15 minutes.The hcw did not seek any medical attention or treatment and is reported to be "ok".This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Ni.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, and system hazard user misuse analysis (shuma).Method: service history, trending and shuma reviewed.The dhr was not reviewed as the assignable cause of this issue is user error.The service history trending was not performed as the lot number of the involved cassette is not available.The trend for the product malfunction code of skin reaction was assessed from (b)(4) 2014.The risk is considered "low." the shuma indicates the risk is "broadly acceptable." the instructions for use (ifu) of the sterrad® 100nx state: "warning! hydrogen peroxide may be present.Wear chemical resistant latex, pvc (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or when disposing of a cassette.Hydrogen peroxide liquid may be present on the cassette, the load or in the chamber." the customer self-identified this issue as user error.No ppe was utilized when handling the used cassette.The severity of the issue was defined as "limited." review of the tracking and trending data did not identify a trend that needed further investigation.The cause of the issue was determined to be inadequate use of ppe.No customer letter will be dispatched for this issue as the customer self-identified the issue as user error.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: ginny stamberger ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 4274764
• MDR Text Key: 17296301
• Report Number: 2084725-2014-00373
• 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
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

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
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 23 YR