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 05/14/2014

Event Type  malfunction  

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide while removing a sterrad® 100nx cassette from its packaging.The hydrogen peroxide indicator on the package had turned red from exposure, but the hcw did not notice.The hcw was not wearing personal protective equipment (ppe) and experienced a slight burning and whiteness on her fingers.The hcw flushed her hand with water for 15 min and did not seek any medical attention/treatment.The customer has reported that the staff has been instructed to always wear gloves when handling sterrad® 100nx cassettes.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

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 failure mode and effects analysis (fmea).The dhr was not reviewed as the lot number of the cassette was not available.The trend for the product malfunction code of skin reaction was assessed from june 2013 through may 2014.No significant trend was found.The fmea revealed the risk priority number (rpn) scores are considered to be acceptable.Per the 100nx cassette instructions for use: observe the leak indicator strip on the wrapped cassette.If the leak indicator strip indicates ¿no leak¿, it is ok to handle the cassette.If the indicator strip indicates a ¿leak¿, do not handle the cassette.No product was returned for further evaluation.Review of the tracking and trending data did not identify a trend.As a result, root cause or assignable cause analysis could not be performed.No further action is required; however, this issue will continue to be monitored.

• 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: ginny stamberger ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 3869532
• MDR Text Key: 4459250
• Report Number: 2084725-2014-00208
• 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: 05/14/2014

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: 1481
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 06/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• 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
• Patient Age: 40 YR