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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 Problem Chemical Spillage (2894)
Patient Problem Skin Irritation (2076)
Event Date 08/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
An international customer reported a healthcare worker (hcw) had skin contact with h2o2 on his wrist from a leaking sterrad 100nx cassette while opening the cassette package.The hcw was wearing personal protective equipment (ppe), but the type of ppe is unknown.The affected area turned yellow.The hcw rinsed the area for 15 minutes.No medical attention was received.Although there are no serious injuries reported in this complaint, this event is being reported as a malfunction subsequent to a serious injury.
 
Manufacturer Narrative
Common device name correction from sterrad®100nx sterilizer to sterrad® equipment.(b)(6).Asp investigation summary: the investigation included a review of the batch record, lot trending, system risk analysis (sra) and photographic analysis.The batch record review did not indicate a deviating quality profile for this batch.No events or deviations were reported that could relate to this issue.Trending analysis by lot number was reviewed from 02/10/2017 to 08/09/2017 and no significant trend was observed.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the sterrad® 100nx cassette was discarded by the customer and not available for return.However, photos of the cassette were sent instead.There were four photos sent.Photo (b)(4) shows an open case with lot 16k008 and a cassette with an open foil wrap.The lot# of this cassette cannot be depicted.The indicator bar on the outer side is not red.There is no indication of a leak in this photo.Photo (b)(4) shows the open foil wrap with the inner part of the indicator stripe being red.This is the normal appearance of the indicator stripe on its inner side.It is not an indication for a leak.The cassette itself looks as if all cells are used/empty.However the low resolution of the photo does not allow to assess details.Photo (b)(4) shows the cassette with its label, and lot# 16k008.This cassette looks as if all cells are still filled to some degree, which would not be the normal appearance of a completely used cassette.No damage can be depicted.The low resolution of the photo does not allow to assess details.Photo (b)(4) shows the cassette with its label, and lot# 16k008.This cassette also looks as if all cells are still filled to some degree.No damage can be depicted.The low resolution of the photo does not allow to assess details.A final conclusion can only be made upon analysis of the field sample.The assignable cause of the issue could not be determined as the product was not available for return and the photos did not allow to assess any details, possibly due to the low resolution of the photos.It is unlikely that there was a performance issue in the sterrad® cassette since the batch record review found no anomalies that would contribute to the issue, and lot history review did not exceed trending.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 92618
Manufacturer (Section G)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key6845664
MDR Text Key85016807
Report Number2084725-2017-00547
Device Sequence Number1
Product Code MLR
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K071345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/09/2017
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 Expiration Date10/29/2017
Device Catalogue Number10144
Device Lot Number16K008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/09/2017
Initial Date FDA Received09/06/2017
Supplement Dates Manufacturer Received12/28/2017
Supplement Dates FDA Received12/29/2017
Date Device Manufactured11/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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