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 06/15/2016

Event Type  malfunction  

Event Description

A customer reported a healthcare worker (hcw) had a skin reaction after removing a sterrad® 100nx cassette from their sterrad® sterilizer.Additional information regarding the event is unknown at this time.Asp will continue to follow up for additional information.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Additional information provided indicates the healthcare worker (hcw) was burned while removing the cassette from the unit, after the cassette had been punctured.During removal, the packaging touched her skin.She was wearing ppe as recommended by instructions for use (ifu).It was reported that the area of contact was on the user's forearm, likely not covered by the ppe worn during handling.The burning sensation lasted for 30 minutes and resolved after rinsing her forearm in water.No medical attention, treatment, or prescriptions were received and patient outcome was stated to be "fine." asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), and review of instruction for use (ifu).Method: actual device not evaluated.Result: no results available since no evaluation performed.Dhr could not be performed without lot number provided.Trending of the lot could not be performed without lot number provided.The sra indicates the risk associated with hazard of 'exposure to toxic or corrosive material 'is "low.The product was not returned for evaluation.It is known that once the cassette is pierced, leakage may occur and there is a risk for user burn by hydrogen peroxide.Ppe is recommended as instructed in the ifu, "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to a liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." the ifu was found to adequately address use of ppe.It was reported that the area of contact was on the user's forearm, likely not covered by the ppe worn during handling.In this case, contact with hydrogen peroxide did not result in permanent impairment or intervention required.The issue will continue to be tracked.Without lot number provided and additional information, further investigation could not be performed.A definitive assignable cause could not be determined.

Manufacturer Narrative

Correction: remove hcw's symptoms lasted 30 minutes to hcw's symptoms lasted one hour.The corrected information was reviewed and determined not to be a serious injury.No medical treatment was received and the symptoms resolved on its own.

• 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: 5787776
• MDR Text Key: 49384774
• Report Number: 2084725-2016-00390
• 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,Followup
• Report Date: 06/15/2016

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: 06/15/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/12/2016; 09/22/2016
• 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