• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 03/08/2017
Event Type  malfunction  
Event Description
A customer reported a healthcare worker (hcw) had a skin reaction touching the side of an intact sterrad® 100nx cassette.The hcw was not wearing gloves and had "skin blanching (white skin)" on the hand.The hcw stated it was "just residue" and "had completely come off" within a couple hours.The hcw washed their hands to resolve the skin reaction and did not seek medical attention.An advanced sterilization products field service engineer (fse) instructed the hcw to use gloves at all times when handling 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, product analysis, trending analysis by lot number, and system risk analysis (sra).The device batch record was not reviewed as the lot number of the cassette was not available.Supplier product evaluation was not performed as the cause of the reported issue is user error and the product is not required for return.Trending analysis by lot number was not reviewed since the lot number was not known.The sra indicates the risk associated with exposure to toxic or corrosive material 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).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6455488
MDR Text Key71583475
Report Number2084725-2017-00164
Device Sequence Number1
Product Code MLR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/08/2017
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 03/08/2017
Initial Date FDA Received04/03/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/26/2017
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
-
-