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 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

Ni.

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 stinging on her hand for "only a minute." the hcw flushed her hand with water for 15 minutes and is reported to have recovered.No medical attention/treatment was sought or received.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation was limited as the suspect cassette was not returned for evaluation and lot number was not made available.The customer was informed to use personal protective equipment (ppe) for handling of a the cassette.The device history record (dhr) could not be reviewed without a lot number available.Trending analysis could not be performed without the lot number available.The system risk analysis (sra) indicates the risk associated to the event is low with exposure to toxic or corrosive material as "limited." 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: 5304562
• MDR Text Key: 33709485
• Report Number: 2084725-2015-00619
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

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: 11/18/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2016
• 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