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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 01/17/2017
Event Type  malfunction  
Manufacturer Narrative
A field service engineer was dispatched to customer site and she/he adjusted the duo pump.Unit meets specifications and was returned to service on 01/17/2017.
 
Event Description
A customer reported a three health care workers (hcw) experienced skin reactions trying to reinsert the sterrad 100nx cassette into the unit after a cancelled cycle.This reported is for (b)(6) who experienced a burn.Details of the affected area are unknown; however, it was reported the hcw did not receive medical attention.The hcw was not wearing personal protective equipment (ppe).The hcw was advised by the advanced sterilization products (asp) representative to always wear ppe when touching cassettes.This event is being reported as a malfunction report subsequent to a serious injury.(b)(4) are related complaints from the same facility.This is two of three 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2017-00075, 2084725-2017-00076 and 2084725-2017-00077.
 
Manufacturer Narrative
Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, lot trending, 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 lot number was unavailable.¿ trending analysis by lot was not reviewed as the lot number was not available.¿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).The customer was advised to always wear proper ppe while handling cassettes 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 Key6330611
MDR Text Key67439825
Report Number2084725-2017-00076
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 01/23/2017
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 01/23/2017
Initial Date FDA Received02/14/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/12/2017
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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