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 01/10/2015

Event Type  malfunction  

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide after opening a new cassette for a sterrad® 100nx.The customer reported the indicator strip on the cassette package did not turn red which would have alerted the hcw to the presence of hydrogen peroxide.The hcw was not wearing personal protective equipment (ppe) and experienced burning, stinging and blanching on her fingertips and palms.The hcw washed the affected areas and did not seek or receive any medical attention/treatment.The hcw reported the reactions lasted 12 hours and is now ¿fine.¿ this event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.This is three of four 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2015-00030, 2084725-2015-00031, 2084725-2015-00032 and 2084725-2015-00033.

Manufacturer Narrative

Manufacturer date: 11/05/2014.Asp investigation summary: 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).Method: service history, trending, fmea and shuma reviewed.The dhr was reviewed and there was an issue in production which is addressed in capa.The service history for the past six months (07/23/2014 to 1/19/2015) did not identify any significant trend.The trend for the product malfunction code of skin reaction was assessed from february 2014 through january 2015.The risk is considered "low." the fmea revealed the risk priority number (rpn) scores are considered to be acceptable.The shuma indicates the risk is "broadly acceptable." testing was not performed as no product was returned.Per the supplier, there was an issue in production; however, as the suspect product was not returned the reported issues could not be confirmed.As a result, there is insufficient information to investigate the alleged product issues.Review of tracking and trending data did not reveal a trend.As a result, root cause was not performed; 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: 4490118
• MDR Text Key: 5563883
• Report Number: 2084725-2015-00032
• 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: 01/15/2015

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
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 02/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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
• Patient Age: 26 YR