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

Catalog Number 10144

Device Problem Chemical Spillage (2894)

Patient Problem Skin Irritation (2076)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a healthcare worker (hcw) had a skin reaction after removing a sterrad 100nx cassette from their sterrad sterilizer.The symptoms included a burning and stinging sensation on both hands that lasted approximately two hours.The hcw was not wearing personal protective equipment at the time of the event and did not seek or receive any medical attention/treatment and is reported to be "normal." this event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Method: actual device not evaluated.Result: no results available since no evaluation performed.Concluson: failure to follow instructions.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, failure mode and effects analysis (fmea), and system risk analysis (sra).Per the supplier dhr review, no anomalies were observed that would contribute to the customer's experienced issue.Trending analysis by lot number was reviewed from six months prior to complaint open date and trending was not exceeded.The fmea was reviewed and indicates that the risk priority numbers (rpn) associated for the failure mode is at an acceptable level.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." the customer was notified to use ppe during handling of sterrad® 100nx cassettes.The issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).

• 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: 5651659
• MDR Text Key: 45095922
• Report Number: 2084725-2016-00286
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

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: 08/01/2017
• Device Catalogue Number: 10144
• Device Lot Number: 16A019
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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