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 03/20/2015

Event Type  malfunction  

Event Description

An international facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide (h2o2) after opening a new sterrad® 100nx cassette.The customer states the h2o2 leak indicator did not discolor which would indicate a possible h2o2 leak.After inserting the cassette into the sterrad® unit the customer disposed the cassette packaging and experienced a burning sensation on his hand.The hcw was not wearing personal protective equipment (ppe).The hcw washed the affected area with water for 15 to 20 minutes and did not seek or receive any medical attention.The symptom lasted for approximately 8 hours and the hcw is reported to be recovered.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Ni.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, and system hazard and 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 service history for the past six months ((b)(4) 2014 to (b)(4) 2015) did not identify any significant trend.The trend for the product malfunction code of skin reaction was assessed from (b)(4) 2014 through (b)(4) 2015.The risk is considered "low." the shuma indicates the risk is "broadly acceptable." the instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a used 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." testing was not performed as no product was returned.Insufficient information is available to investigate as the reported issues could not be confirmed.In the event field samples become available, this complaint will be reassessed.Review of tracking and trending data did not reveal a trend.As a result, root or assignable cause was not required; therefore, no further investigation is necessary at this time.

• 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: 4680889
• MDR Text Key: 5625633
• Report Number: 2084725-2015-00077
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/20/2015

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 Catalogue Number: 10144
• Device Lot Number: 14A134
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• 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