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

Catalog Number 10144

Device Problem Chemical Spillage (2894)

Patient Problem Skin Irritation (2076)

Event Date 05/24/2016

Event Type  malfunction  

Event Description

A customer reported a healthcare worker (hcw) reported a burn on both sides of the index finger from contact with h2o2 while opening a package of cassettes.The hcw washed the affected site with running water, the hcw was not wearing personal protective equipment (ppe) at the time of the event.The customer was advised to wear always ppe.The size of the affected area was 1 centimeter and turned white in color and sought medical attention.The site healed within one day without medical treatment.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 batch record, trending of the lot, supplier product evaluation, visual analysis and system risk analysis (sra).The batch record was not reviewed as the lot number of the cassette was not available.The product was not available for return as it was discarded by the customer.The supplier investigation was not performed since the product was not returned.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a 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).A customer letter was sent advising the customer to wear proper ppe to avoid this issue in the future.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
• MDR Report Key: 5724976
• MDR Text Key: 47397449
• Report Number: 2084725-2016-00352
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

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: 05/24/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• 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