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 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

Ni.

Event Description

An international customer reported a healthcare worker (hcw) came in contact with hydrogen peroxide (h2o2) while handling a cassette for a sterrad 100nx unit.The contact occurred prior to inserting the cassette into the unit.The hcw was not wearing gloves and received "h2o2 burns." the severity of the burns and the current health status of the hcw is unknown.This event is being reported as a malfunction report subsequent to a serious injury.1-qtadva and 1-qtadwy 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: 2084725-2015-00513 and 2084725-2084725-2015-00514.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included a review of the batch record, lot trending, and system risk analysis (sra).The batch record review did not indicate a deviating quality profile for this batch.No events or deviations were reported that could relate to this issue; trending analysis by lot number was reviewed from 07/29/2015 to 10/14/2015 and trending was not exceeded; the sra indicates the risk associated with improper handling of a cassette is "low." the sterrad® 100nx cassette was not returned for functional testing.The likely assignable cause can be attributed to user error.The healthcare worker who experienced the skin reaction was not wearing personal protective equipment and has subsequently been retrained.It is unlikely there was a performance issue with the sterrad® 100nx cassette as the batch record review found no anomalies that would contribute to the issue and lot history review did not exceed trending.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: 5212946
• MDR Text Key: 30843918
• Report Number: 2084725-2015-00514
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/14/2015

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 Expiration Date: 07/23/2016
• 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: 10/14/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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