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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR)

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ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) Back to Search Results
Catalog Number 10104
Device Problems Chemical Problem; Human-Device Interface Problem
Event Date 04/30/2010
Event Type  Malfunction  
Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history, the service and complaint history, trending by product line and system serial number, health hazard evaluation and the system hazard and user misuse analysis. The dhr (device history review) for the sterrad 100nx system (serial number (b)(4)) confirmed that the product met all specifications at the time of release. The service and complaint history for the sterrad 100nx did not reveal a trend for skin contact - h2o2. Trending analysis for skin contact - h2o2 issues associated to the sterrad 100nx did not indicate a significant trend. (b)(4). There was no product returned to asp for investigation.

 
Event Description

An experienced healthcare worker (hcw) experienced h2o2 contact while removing a load from a sterrad 100nx sterilizer completed cycle. The hcw noticed a liquid substance on the outside of the package while handling the package. The hcw experienced the burn inside her forearm. She rinsed the site with water for fifteen minutes. The symptoms resolved in a couple of minutes. The hcw was not wearing ppe.

 
Manufacturer Narrative

Instrument tray - part and serial #s unknown. The ifu states the following: warning! hydrogen peroxide is corrosive concentrated hydrogen peroxide is corrosive to skin, eyes, nose, throat, lungs, and the gastrointestinal tract. Always wear chemical resistant latex, pvc (vinyl), or nitrile gloves when removing items from the sterilizer following a cancelled cycle or if any moisture is noted on items in the load following a completed cycle. Per the ifu, all items must be cleaned and thoroughly dried before loading into the sterilizer. Loads containing moisture may cause cycle cancellation. The asp field service engineer (fse) assessed the unit onsite. She found the machine operating properly. She tested the system and ran a empty cycle that completed. She returned the system to the customer for use.

 
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Brand NameSTERRAD 100NX STERILIZER
Type of DeviceSTERRAD EQUIPMENT (MLR)
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer (Section G)
ADVANCED STERILIZATION PRODUCTS
irvine CA 92618
Manufacturer Contact
ginny stamberger
33 technology drive
irvine , CA 92618
9497893837
MDR Report Key1698231
Report Number2084725-2010-00186
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type Invalid data
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number10104
Is The Reporter A Health Professional? No
Date Manufacturer Received10/20/2010
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 Invalid Data

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