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 02/17/2015

Event Type  malfunction  

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide while touching a used cassette from a sterrad® 100nx.The hcw was not wearing personal protective equipment (ppe) and experienced staining on her finger tips.The hcw flushed her hands with soap and water.The hcw did not seek any medical attention.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

Ni.

Manufacturer Narrative

Device information - correcting expiration date from "na" to 09/12/2015.Manufacturer date: 09/17/2014.Asp investigation summary: the investigation included a review of the batch record, trending of the product malfunction code, failure mode and effects analysis (fmea), and system risk analysis (sra).Method: trending, fmea and sra reviewed.¿the batch record was reviewed and did not reveal any indication of any quality issues for this batch.There were no events or deviations that could relate to this issue.¿(b)(4) ¿the fmea revealed the risk priority number (rpn) scores are considered to be at an acceptable level.¿the sra shows the risk for exposure to toxic or corrosive material to be "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 cassette was discarded by the customer and therefore not returned.As a result, no supplier testing was completed.The customer provided photos of the affected cassette.The photos show spots of clear liquid within the plastic bag in which it was placed.However, it is unknown which cell the liquid originated from and whether the cassette was leaking upon opening.Service was not dispatched for the concommitant sterrad® unit as the customer suspected the failure was with the cassette only.The customer changed to another cassette and the sterrad® unit functioned properly.Also, review of the service history of the sterrad® unit indicates no problems were reported against the unit for leaking cassette/skin reaction issues.The assignable cause of the reported issue is user error as no personal protective equipment (ppe) was used when handling a used cassette.A customer letter will be sent reinforcing the importance of wearing appropriate ppe when handling leaking cassettes.Asp will continue to monitor this issue.

• 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: 4541644
• MDR Text Key: 5507971
• Report Number: 2084725-2015-00044
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2015

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 Expiration Date: 09/12/2015
• Device Catalogue Number: 10144
• Device Lot Number: 14I061
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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
• Patient Age: 32 YR