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

Catalog Number 10144

Device Problem Chemical Problem (2893)

Patient Problem Skin Irritation (2076)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported a healthcare worker (hcw) received a skin reaction on his/her fingers while trying to insert a sterrad® 100nx cassette into the sterrad® 100nx sterilizer.The customer was not wearing gloves and the affected area turned white.The affected area was washed with soap and water and the white marks were gone in approximately three hours.No medical attention was sought and the hcw is reported to be fine.The customer was advised to always wear personal protective equipment (ppe), specifically gloves while handling cassettes.There are no serious injuries reported in this complaint, and the h2o2 skin reaction resolved after washing and without medical treatment.Furthermore, 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.However, this skin reaction was due to contact with h2o2 from sterrad® 100nx cassettes; therefore, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

The investigation included a review of the device batch record, lot trending, and system risk analysis (sra).The batch record was reviewed by the supplier and did not reveal any indication of a deviating quality profile for this lot.Trending analysis by lot number was reviewed from march 2018 to september 2018 and trending was not exceeded.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) was not using proper personal protective equipment (ppe) while handling the cassette.The customer was advised always wear ppe when handling cassettes.The issue will continue to be tracked and trended.(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: 7873273
• MDR Text Key: 120242268
• Report Number: 2084725-2018-00710
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 10144
• Device Lot Number: 18E081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD® 100NX STERILIZER SERIAL #: (B)(4)