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U.S. Department of Health and Human Services

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

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ADVANCED STERILIZATION PRODUCTS STERRAD 100NX CASSETTE; STERRAD 100NX STERILIZER Back to Search Results
Catalog Number 10144
Device Problems Chemical Spillage (2894); Device Handling Problem (3265)
Patient Problem Skin Irritation (2076)
Event Date 03/09/2017
Event Type  malfunction  
Event Description
A customer reported a healthcare worker (hcw) received a skin reaction on their arm while inserting a new sterrad® 100nx cassette into their sterrad® sterilizer.The affected area turned white and was washed with running water.The affected area healed within one day without receiving medical attention.It is unknown if the hcw was wearing personal protective equipment at the time of the event.An advanced sterilization products (asp) representative advised the customer on proper handling of cassettes.This event is being reported as a malfunction report subsequent to a serious injury.
 
Manufacturer Narrative
Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending analysis of lot number, 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 cassette was not returned.Trending by lot number could not be performed as the lot number was unknown.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe) as per the instructions for use (ifu).A customer letter was sent advising the customer to wear proper ppe to avoid this issue in the future.The issue will continue to be tracked and trended.
 
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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
9497893837
MDR Report Key6455552
MDR Text Key71579295
Report Number2084725-2017-00168
Device Sequence Number1
Product Code MLR
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/09/2017
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 Number10144
Other Device ID Number10144
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/09/2017
Initial Date FDA Received04/03/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/07/2017
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 Number1
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