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 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported two healthcare workers (hcw's) had skin reactions removing the sterrad® 100nx cassette from their sterrad® 100nx sterilizer.The users damaged the cassette attempting to remove it from the unit and came into contact with h2o2.Details of the event are unknown at this time.Asp will continue to follow up for information.This event is being reported as a malfunction report subsequent to a serious injury.Hcw#1 is captured on (b)(4) and hcw#2 is captured on (b)(4).This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2016-00469 and 2084725-2016-00468.

Manufacturer Narrative

Additional information provided by the affiliate and a review of the complaint file has concluded the reported event only involved one health care worker and not two as originally reported by the customer.As such, this complaint will be voided.The issue of one health care worker experiencing skin reactions removing the sterrad® 100nx cassette from their sterrad® 100nx sterilizer has been reported under (b)(4), mdr # 2084725-2016-00469.

• 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 Key: 5881110
• MDR Text Key: 52276171
• Report Number: 2084725-2016-00468
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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 Number: 10144
• Other Device ID Number: 10144
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1