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

Catalog Number 10144

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

Patient Problem Skin Irritation (2076)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

The customer reported two healthcare workers (hcw) came into contact with h2o2 on their hands after removing a sterrad® 100nx cassette from their sterrad® sterilizer.This file addresses the hcw#2, who "touched the cassette after it was inside the machine".The hcw was not wearing personal protective equipment at the time of the event and her skin turned white.The hcw was sent to the emergency room and the issue was resolved by "normal washing" of hands.The "physician did not treat patient with anything¿ and the skin reaction ¿went away after one day¿ and the hcw is reported be "fine".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 event is being reported as a malfunction subsequent to a serious injury.(b)(4) are related complaints from the same facility.This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2017-00189 and 2084725-2017-00190.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, lot trending, system risk analysis (sra) and supplier product evaluation.The batch record and trending analysis by lot number was not reviewed as the lot number was not available after multiple attempts were made with the customer for additional information.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." supplier product evaluation was not performed as it was determined to be a user error.The customer handled the cassette without the use of proper personal protective equipment (ppe).The issue has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe).The customer letter was sent reminding the user to always wear ppe when handling cassettes.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: 6486778
• MDR Text Key: 72592529
• Report Number: 2084725-2017-00190
• 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
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 07/21/2017
• 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