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 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported two healthcare workers (hcw) had skin reactions removing the sterrad® 100nx cassette from their sterrad® 100nx sterilizer.The users damaged the cassette attempting to remove it from the unit and came into contact with h2o2.Details of the event are unknown at this time.Asp will continue to follow up for information.This event is being reported as a malfunction report subsequent to a serious injury.Hcw#1 is captured on (b)(4) and hcw#2 is captured on (b)(4).This is one of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2016-00469 and 2084725-2016-00468.

Manufacturer Narrative

The customer stated there was only one hcw affected, not two as originally reported.Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending by lot number,, concomitant product evaluation and system risk analysis (sra).The batch record was not reviewed as the lot number of the cassette was not available.Supplier product evaluation was not performed as the cause of the reported issue is user error.Trending analysis by lot number was not performed as the lot number was not available.The concomitant sterrad 100nx was evaluated and the fse determined the cassette transporter was misaligned.A mechanical adjustment was performed and the fse reported the issue was resolved and the unit was working to specifications.The sra indicates the risk associated with exposure to toxic or corrosive material e is "low." the instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." the issue has been attributed to user error as the healthcare worker (hcw) removed the cassette without utilizing proper personal protective equipment (ppe).On-site training at the site was completed with the customer regarding the importance of wearing ppe to avoid this issue in the future.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 ; 9497893837
• MDR Report Key: 5881107
• MDR Text Key: 52276135
• Report Number: 2084725-2016-00469
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 07/21/2016

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: 07/21/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• 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