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

Catalog Number 10144

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

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a health care worker (hcw) received an h2o2 skin reaction on their hands while removing a sterrad® 100nx cassette from the sterrad® 100nx sterilizer.The hcw was not wearing personal protective equipment (ppe).The affected area on both thumbs had ¿white spots¿ that lasted approximately four hours.The affected areas were washed with soap and water.No medical attention was required.The hcw continued to work until the end of their shift, and the hcw reported she was ¿fine.¿ 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 a sterrad 100nx cassette; therefore, this event is being reported as a malfunction subsequent to a serious injury.This complaint will be re-assessed if new information becomes available.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, functional analysis 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 cause of the reported issue is user error.¿no functional analysis was performed as the customer stated the cassette was discarded.¿ the sra shows the risk for exposure to toxic or corrosive material to be "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 asp field service engineer advised the customer to always wear proper ppe to avoid this issue in the future.Asp will continue to track and trend this issue.

• Brand Name: STERRAD® 100 NX CASSETTE
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7260825
• MDR Text Key: 99894166
• Report Number: 2084725-2018-00527
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• 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: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1