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

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.

• 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 Key: 6845664
• MDR Text Key: 85016807
• Report Number: 2084725-2017-00547
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• 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 Date: 10/29/2017
• Device Catalogue Number: 10144
• Device Lot Number: 16K008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 12/28/2017
• Supplement Dates FDA Received: 12/29/2017
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1