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

Catalog Number 10144

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894); Device Handling Problem (3265)

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 10/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported a healthcare worker (hcw) had a sustained a small peroxide burn to the hand/finger while she was trying to see if the sterrad® 100nx cassette was stuck in the unit and she reached with her hand to fix it.The hcw was not wearing gloves and her left index fingertip turned white and ¿burned a little¿.She washed her hands and her symptoms were gone in a couple hours.She did not receive medical attention and reported she was ¿good¿.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

The investigation included a review of the device batch record, supplier product evaluation, complaint trending of the lot number, 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 product was discarded by the customer and not returned.Complaint trending by lot number was not performed as the lot number was not available.The sra indicates the risk associated with improper handling of a cassette 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 customer was advised to always wear ppe while handling cassettes.The issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).

• Brand Name: STERRAD® 100NX CASSETTE
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 7006680
• MDR Text Key: 92211892
• Report Number: 2084725-2017-00646
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention