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

Catalog Number 10144

Device Problems Chemical Spillage (2894); Device Handling Problem (3265)

Patient Problem Skin Irritation (2076)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

A customer reported a healthcare worker (hcw) received a skin reaction on their arm while inserting a new sterrad® 100nx cassette into their sterrad® sterilizer.The affected area turned white and was washed with running water.The affected area healed within one day without receiving medical attention.It is unknown if the hcw was wearing personal protective equipment at the time of the event.An advanced sterilization products (asp) representative advised the customer on proper handling of cassettes.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending analysis of lot number, and system risk analysis (sra).The batch record was not reviewed as the lot number of the cassette was not available.Supplier product evaluation was not performed as the cassette was not returned.Trending by lot number could not be performed as the lot number was unknown.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe) as per the instructions for use (ifu).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 ; 9497893837
• MDR Report Key: 6455552
• MDR Text Key: 71579295
• Report Number: 2084725-2017-00168
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

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: 03/09/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2017
• 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