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 02/10/2015

Event Type  malfunction  

Event Description

A facility reported a healthcare worker (hcw) came in contact with hyrdrogen peroxide (h202) while removing a used cassette from a sterrad 100nx.The hcw experienced staining on his finger only with no irritation.Hcw was advised to flush the affected area with water.The hcw did not seek any medical attention or treatment.The event isi being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Ni.

Manufacturer Narrative

(b)(4).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 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.The trend for the product malfunction code of skin reaction was assessed from march 2014 through february 2014.There was no significant trend.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 issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).A customer letter was sent advising the customer to wear proper ppe to avoid this issue in the future.Review of tracking and trending data did not reveal a trend.As a result, root cause was not performed; therefore, no further investigation is necessary at this time.

• 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: 4528973
• MDR Text Key: 5507124
• Report Number: 2084725-2015-00040
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2015

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
• Device Lot Number: N/A
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 02/19/2015
• 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