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

Catalog Number 10144

Device Problems Chemical Spillage (2894); Device Handling Problem (3265)

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to customer site.The fse found an incorrect collection box being used.Unit meets specifications and was returned to service on 09/15/2016.

Event Description

Three health care workers (hcw) reported h2o2 contact while changing a sterrad 100nx cassette collection box.The hcw's were not wearing personal protective equipment (ppe).There were no serious injuries reported in this event.Hcw#2 who stated his hand and finger turned white and was "itchy".The affected area was washed with soap and water and his symptoms lasted 15-30 minutes.No medical attention was sought and the hcw continued to work.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: 2084725-2016-00597, 2084725-2016-00596 and 2084725-2016-00598.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending by lot number, 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 product was not returned for evaluation and the issue was determined to be user error.Trending by lot number was not reviewed since the lot number was not available.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).It was confirmed that the healthcare workers were retrained in regards to always wear ppe while handling cassettes.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 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: 6022852
• MDR Text Key: 57273975
• Report Number: 2084725-2016-00596
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2017
• 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 Number: 1