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 10/03/2014

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 "white staining and itchiness for approximately 24 hours." the hcw flushed his hand with water.No medical attention was sought or received.The hcw is reported to be "100% ok." this event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Ni.

Manufacturer Narrative

Manufacturer date: 07/09/2014.Asp investigation summary: the investigation included a review of the batch record review, service history, trending of the product malfunction code and lot number, and system hazard user misuse analysis (shuma).Method - service history, trending and shuma reviewed.¿the batch record review was reviewed and no issues relating the failure mode were noted.The batch met manufacturer specifications at the time of release.¿the service history for the past six months (04/05/2014 to 10/02/2014) did not identify any significant trend.¿the trend for the product malfunction code of skin reaction was assessed from january 2014 through december 2014.The risk is considered "acceptable after being reduced as low as possible." ¿ trending analysis by lot number was reviewed from 07/09/2014 to 10/02/2014.There were no similar incidents within this time frame.¿the shuma indicates the risk is "broadly acceptable." the instructions for use (ifu) of the sterrad® 100nx state: "warning! hydrogen peroxide may be present.Wear chemical resistant latex, pvc (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or when disposing of a cassette.Hydrogen peroxide liquid may be present on the cassette, the load or in the chamber." testing was not performed as there was no product returned.The most likely assignable cause is that the customer did not follow the product's ifu to wear ppe when handling a used cassette.The severity of the issue was defined as "moderate." the customer was sent a letter advising to review the proper handling of used cassettes.Review of tracking and trending data did not reveal a trend that needed further investigation.

• 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: aaron goodstein ; irvine, CA 92618 ; 7863136118
• MDR Report Key: 4182562
• MDR Text Key: 5094067
• Report Number: 2084725-2014-00341
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2014

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
• Device Lot Number: 14G028
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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