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

Catalog Number 10144

Device Problems Fluid/Blood Leak (1250); Chemical Problem (2893); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2017

Event Type  malfunction  

Event Description

The customer reported white powder was found on a new and unused sterrad® 100nx cassette when the plastic wrap was opened.The color of ci of the cassette had not change indicating a h2o2 leak.There was no report of infection, injury or harm to patient(s) associated with this issue.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

The batch record review did not reveal any indication on a deviating quality profile for this batch.No events or deviations were reported.All in-process controls corresponded to the specification.

Manufacturer Narrative

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).¿ trending analysis by lot number was reviewed from 07/29/2016 to 01/25/2017 and trending was not exceeded.¿supplier product evaluation was not performed as the suspect cassette was not returned for evaluation.¿the sra indicates the risk associated with a quality problem with no impact on safety 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." it is unlikely that there was a performance issue in the sterrad® cassette product since the batch record review found no anomalies that would contribute to the issue, and lot history review did not exceed trending.The product was not returned for analysis and could not be evaluated.The cause could not be verified.

• 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: 6339635
• MDR Text Key: 67807053
• Report Number: 2084725-2017-00078
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/25/2017

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: 07/19/2017
• Device Catalogue Number: 10144
• Device Lot Number: 16H077
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2017; 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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