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 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad 100nx cassette.Common device - the correct common device is sterrad 100nx sterilizer.Catalog number - the correct catalog number is 10144_90.Lot number - the correct lot number is 15l082.Expiration date - the correct expiration date is 12/09/2016.(b)(4).

Event Description

It was reported that a healthcare worker (hcw) received a h2o2 burn on the fingers while inserting a new sterrad® 100nx cassette into a sterrad® 100nx unit.The hcw was not wearing personal protective equipment (ppe).The hcw's symptoms included burning and discoloration on his right hand fingers that lasted several hours and did not subside.The hcw went to the emergency room where the affected area was rinsed in cold water.The symptoms went away.No other treatments were prescribed.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending of the product malfunction code, and system risk analysis (sra).The batch record was reviewed and did not reveal any indication on a deviating quality profile for this batch.No events or deviations were reported that could relate to this issue.Trending analysis by lot number was reviewed from 01/20/2016 to 07/18/2016 and trending was not exceeded.The product was not returned for evaluation.The sra indicates the risk associated with improper handling of a cassette is "low." the issue has been attributed to user error as the healthcare worker (hcw) was not wearing personal protective equipment (ppe) while handling the cassette as instructed in the instructions for use (ifu).A customer letter was sent advising the customer to wear proper ppe to avoid this issue in the future.The issue will 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 ; 9497893837
• MDR Report Key: 5845765
• MDR Text Key: 51111880
• Report Number: 2084725-2016-00452
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

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 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: 04/28/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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