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

Catalog Number 10144

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

Patient Problem Skin Irritation (2076)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Asp complaint ref #: (b)(4).

Event Description

A customer reported a healthcare worker (hcw) experienced ¿peroxide burns¿ after removing a sterrad® 100nx cassette from their sterrad® 100nx sterilizer collection box.The hcw was not wearing personal protective equipment (ppe) while handling the cassette.No further information regarding the healthcare worker is known at this time; however, the limited information received to date suggests the h2o2 skin reaction was not serious and there is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure.Advanced sterilization products will continue to follow-up for additional information.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 history record (dhr), trending analysis by lot number, and system risk analysis (sra).Lot number was unavailable; therefore, dhr review could not be performed.Lot trending was not performed as the lot number of the cassette was not available.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the cassette was not available for return and further analysis since the customer discarded the cassette.The assignable cause of the skin reaction issue while a cassette was removed from the collection box can be attributed to user error as the healthcare worker was not wearing personal protective equipment (ppe) while handling a cassette.The customer was advised always wear ppe when handling cassettes.The issue will continue to be tracked and trended.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: 8117661
• MDR Text Key: 129158240
• Report Number: 2084725-2018-00771
• 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
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD 100NX STERILIZER, SERIAL # (B)(6)