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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 No Patient Involvement (2645)
Event Date 05/11/2017
Event Type  malfunction  
Event Description
A customer reported the color indicator on the sleeve of a brand new 100nx cassette was discolored when opening the cassette package.The color was "red" indicating h2o2 leakage from the cassette.There was no report of injury or harm to patient(s) associated with this issue.This event is being reported as a malfunction report subsequent to a serious injury.
 
Manufacturer Narrative
Supplier product evaluation indicates one (1) open cassette was received.The foil wrapping of the cassette was open.The indicator stripe turned red.Through the plastic bags it can be seen that cell #10 is empty.No further investigation is possible for security reasons: the cassette and foil wrapping is completely soaked with h2o2.Due to the appearance of the field sample (opened foil wrapping) it can not be determined whether the cassette was delivered with this defect.The foil wrapping should not be opened once the indicator stripe turned red.Per the supplier, 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 complaint issue.All in-process controls corresponded to specifications.
 
Manufacturer Narrative
Asp investigation summary: the investigation included a review of the batch history record (bhr), trending of lot number, system risk analysis (sra), supplier product evaluation and concomitant product evaluation.Trending analysis by lot number was reviewed from 03/09/2017 to 05/14/2017 and trending was not exceeded.The sra indicates the risk associated to toxic or corrosive material is "low." product testing by the supplier was unable to confirm the customer¿s reported issue.The cause could not be verified.It is unlikely there was a performance issue with the sterrad® 100nx cassette as 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 CA 92618
Manufacturer (Section G)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer Contact
joaquin kurz
irvine, CA 92618
9497893837
MDR Report Key6619180
MDR Text Key76892062
Report Number2084725-2017-00281
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,Followup
Report Date 05/11/2017
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 Date03/04/2018
Device Catalogue Number10144
Device Lot Number17B086
Other Device ID Number10144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/11/2017
Initial Date FDA Received06/07/2017
Supplement Dates Manufacturer ReceivedNot provided
07/27/2017
Supplement Dates FDA Received06/27/2017
07/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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