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 04/09/2014

Event Type  malfunction  

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide while touching a used cassette from a sterrad 100nx.The hcw was not wearing personal protective equipment (ppe) and experienced stinging on her hand for 10 minutes.The hcw flushed her hand with water for 15 min and washed it with soap.The hcw then visited the onsite doctor who diagnosed a chemical burn.The doctor advised the hcw to continue flushing her hand with water and was immediately cleared to return to work.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Ni.

Manufacturer Narrative

The investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, failure mode and effects analysis (fmea) and system hazard and user misuse analysis (shuma).The dhr was not reviewed as the lot number of the cassette was not available.The service history could not be trended as no lot number is available.The trend for the product malfunction code of skin reaction was assessed from may 2013 through april 2014.The risk highest risk is considered "as low as reasonably practicable." the fmea revealed the risk priority number (rpn) scores are considered to be acceptable.The shuma indicates the risk to be "broadly acceptable." no product was returned for further evaluation.Review of the tracking and trending data did not identify a trend.As a result, root cause or assignable cause analysis could not be performed.No further action is required; however, this issue will continue to be monitored.

• 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: ginny stamberger ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 3776758
• MDR Text Key: 4446442
• Report Number: 2084725-2014-00159
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2014

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: 06/05/2014
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2014
• 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