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

Model Number 10144

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Skin Irritation (2076)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The batch history review (bhr) was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.(b)(4).

Event Description

A customer reported a healthcare worker (hcw) had a skin reaction on his hand after opening the package of a sterrad® 100nx cassette.The hcw did not notice the cassette was leaking peroxide.The hcw experienced redness on the palm of the hand.It is unknown if the hcw was wearing personal protective equipment.Advanced sterilization products (asp) has requested additional information, but has received nothing further to date.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

(b)(6).Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending analysis by lot number, and system risk analysis (sra).Supplier product evaluation was not performed since the product was not available for return.The sra indicates the risk associated with toxic or corrosive material is "low." trending analysis by lot number was reviewed from 02/17/2017 to 08/16/2017 and no significant trend was observed.There is insufficient information to determine an assignable cause.It is unlikely that there was a performance issue with the sterrad® cassette as the batch record review found no anomalies that would contribute to the issue, and lot history review revealed trending was not exceeded.The product was not returned for analysis and therefore, could not be evaluated.The issue will continue to be tracked and trended.

• Brand Name: STERRAD®100NX CASSETTE
• Type of Device: STERRAD®100NX
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine ; 949789-383
• MDR Report Key: 6852460
• MDR Text Key: 85596489
• Report Number: 2084725-2017-00549
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• 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: 08/15/2017

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: 04/30/2018
• Device Model Number: 10144
• Device Catalogue Number: 10144
• Device Lot Number: 17D043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 11/11/2017
• Supplement Dates FDA Received: 11/16/2017
• Date Device Manufactured: 05/05/2017
• 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