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 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

An international customer reported a healthcare worker (hcw) came in contact with hydrogen peroxide from a new cassette while inserting it into a sterrad® 100nx.The hcw was not wearing personal protective equipment (ppe).The resulting reaction and severity of the hydrogen peroxide contact is unknown.It is also unknown if the hcw received any medical attention or treatment.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Additional manufacturer narrative: the healthcare worker (hcw) experienced a stinging sensation and white discoloration on his/her fingers.The hcw did not seek or receive any medical attention/treatment.The hcw is reported to be healthy.Asp investigation summary: : the investigation included a review of the batch record, lot trending, failure mode and effects analysis (fmea), 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 (b)(6) 2015 to (b)(6) 2015 and trending was not exceeded.The fmea revealed the risk priority number (rpn) scores are considered to be acceptable.The sra indicates the risk associated with improper handling of a cassette is "low." the sterrad® 100nx cassette was not returned for functional testing.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 cause could not be verified.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: 5262924
• MDR Text Key: 32579381
• Report Number: 2084725-2015-00583
• 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: 11/04/2015

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
• Device Lot Number: 15G098
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• 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