MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX CASSETTE; STERRAD 100NX STERILIZER

Catalog Number 10144

Device Problem Chemical Spillage (2894)

Patient Problem Skin Irritation (2076)

Event Date 05/23/2016

Event Type  malfunction  

Event Description

A customer reported a healthcare worker (hcw) had a skin irritation on the palm of her hand handling a sterrad® 100nx cassette.Details of how this incident happened and extent of injury are unknown at this time.Asp will continue to follow up for additional information.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Result: packaging problem.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), and product return analysis.The dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.Trending analysis by lot number was reviewed from six months prior to complaint open date (11/26/2015 to 05/24/2016) and trending was not exceeded.The sra indicates the risk associated with hazard of 'exposure to toxic or corrosive material' is "low." the suspect product was returned for visual analysis.Evaluation of the cassette identified a cleft in the upper part of cell six (6) near the piercing zone.It is possible that this damage could have been caused by mishandling during packaging, however, the hole is big enough that a hydrogen peroxide leak would have been easily detected prior to shipment.The complaint is confirmed, however, a defintive cause could not be determined.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: 5724959
• MDR Text Key: 47398401
• Report Number: 2084725-2016-00350
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

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 Expiration Date: 01/22/2017
• Device Catalogue Number: 10144
• Device Lot Number: 16A102
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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