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

Model Number 10144

Device Problems Chemical Problem (2893); Device Handling Problem (3265)

Patient Problem Skin Irritation (2076)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: sterrad® 100nx sterilizer, serial # (b)(4).Initial reporter phone #: (b)(6).Asp complaint ref #: (b)(4).

Event Description

A customer reported a healthcare worker (hcw) had a skin reaction on their index and middle finger after removing a sterrad® 100nx cassette from their sterrad® sterilizer.The hcw was not wearing personal protective equipment (ppe).The symptoms included a ¿prickle¿ feeling, and the affected area turned white.The healthcare worker washed the affected area with running water, and the affected area healed the same day without seeking medical attention.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device batch history record, supplier product evaluation, trending analysis of lot number, and system risk analysis (sra).Trending analysis by lot number was reviewed for the previous six months from open date and trending was not exceeded.The sra indicates the risk associated with improper handling of a cassette 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 issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).The customer was advised on how to dispose of used cassettes per the instructions for use and to always wear appropriate ppe while handling cassettes.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

Manufacturer Narrative

H4: device manufacture date: correction from 9/3/2020 to 3/9/2020.Two healthcare workers received a skin reaction while removing the sterrad 100nx cassette from the sterilizer.This is for hcw #1.Please reference asp complaint ref #: (b)(4) and 2084725-2020-00044 for hcw #2.Asp complaint ref #: (b)(4).

Manufacturer Narrative

The batch record review did not reveal any indication on a deviating quality profile for this batch.No quality issues were reported.All in-process controls corresponded to the specification.Two cassettes were returned for analysis.All cells from both cassettes were punctured / used, which indicate the cassettes were accepted and fully used by the customer.Human contact with a cassette leak can only occur if the customer attempts to collect fully used cassettes from the disposal box without gloves as per the ifu.The complaint cannot be confirmed.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD® 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 10196662
• MDR Text Key: 197600680
• Report Number: 2084725-2020-00043
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014903
• UDI-Public: 10705037014903
• Combination Product (y/n): N
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: 10144
• Device Catalogue Number: 10144
• Device Lot Number: 20B039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1