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

Catalog Number 10144

Device Problem Defective Component (2292)

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

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Asp complaint ref #: (b)(4).

Event Description

A customer reported a health care worker (hcw) experienced a h2o2 skin reaction on their hands after opening a sterrad 100nx cassette from its packaging.The hcw was not wearing gloves and symptoms were described as ¿burning and tingling¿ and the affected area turned white.The hcw flushed the affected area with water, and the sensation resolved after a few minutes.It was also reported the white color lasted one day.The hcw did not receive medical treatment for the skin reaction and is reported to be back to ¿normal¿ and back at work.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending of the product malfunction code, retains testing and system risk analysis (sra).Supplier product evaluation was not performed as the product was not available for return.Trending analysis by lot number was reviewed for the previous six months from open date and trending was not exceeded.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).The customer was retrained on proper handling of cassettes, disposal box, and use of ppe.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

Manufacturer Narrative

D4: expiration date correction from (b)(6) 2020 to (b)(6) 2020 the batch record review did not reveal any indication on a deviating quality profile for this batch.All in-process controls corresponded to the specification.Retain samples were inspected.A total of 4 cassettes were inspected: 2 cassettes from beginning of batch lot and 2 cassettes from the end of the batch lot were retained and inspected.The leak indicator color on both sides of all cassettes were white indicating no signs for leaking h2o2.All cassettes were opened and checked for signs of leak.All four cassettes didn¿t show any signs of leak.Neither are there any other visually detectable deviations from specifications.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10174285
• MDR Text Key: 196795829
• Report Number: 2084725-2020-50138
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (y/n): N
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Catalogue Number: 10144
• Device Lot Number: 19F028
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1