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

Catalog Number 10144

Device Problems Leak/Splash (1354); Device Handling Problem (3265)

Patient Problem Skin Irritation (2076)

Event Date 12/27/2016

Event Type  malfunction  

Event Description

A customer reported a healthcare worker (hcw) had a skin reaction after removing a sterrad® 100nx cassette from the cassette disposal box of the sterrad® sterilizer.The hcw reportedly developed a white spot on her finger from the h2o2 exposure.She washed the affected area with water, and within 12 hours the white was gone.She did not receive medical attention, and reported to be ¿fine¿.The hcw was not wearing personal protective equipment at the time of the event.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 the lot number, and system risk analysis (sra).The device batch record, supplier product evaluation and trending analysis by lot number was not reviewed as the lot number of the cassette was not available.The sra indicates the risk associated with exposure to toxic and corrosive material is "low." the product was not available for return and analysis.The issue has been attributed to user error as it was determined that the healthcare worker (hcw) handled the cassette without utilizing proper personal protective equipment (ppe).A customer letter was sent advising the customer to wear proper ppe to avoid this issue in the future.No further investigation is necessary at this time.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: 6248232
• MDR Text Key: 64721987
• Report Number: 2084725-2017-00021
• 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,Followup
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Device Lot Number: N/A
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2017
• 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