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

Catalog Number 10144

Device Problem Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2017

Event Type  malfunction  

Event Description

A customer reported the color indicator on the sleeve of a brand new 100nx cassette was discolored when opening the cassette package.The color was "red" indicating h2o2 leakage from the cassette.There was no report of 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

Supplier product evaluation indicates one (1) open cassette was received.The foil wrapping of the cassette was open.The indicator stripe turned red.Through the plastic bags it can be seen that cell #10 is empty.No further investigation is possible for security reasons: the cassette and foil wrapping is completely soaked with h2o2.Due to the appearance of the field sample (opened foil wrapping) it can not be determined whether the cassette was delivered with this defect.The foil wrapping should not be opened once the indicator stripe turned red.Per the supplier, 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 complaint issue.All in-process controls corresponded to specifications.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the batch history record (bhr), trending of lot number, system risk analysis (sra), supplier product evaluation and concomitant product evaluation.Trending analysis by lot number was reviewed from 03/09/2017 to 05/14/2017 and trending was not exceeded.The sra indicates the risk associated to toxic or corrosive material is "low." product testing by the supplier was unable to confirm the customer¿s reported issue.The cause could not be verified.It is unlikely there was a performance issue with the sterrad® 100nx cassette as 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 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: 6619180
• MDR Text Key: 76892062
• Report Number: 2084725-2017-00281
• 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: 05/11/2017

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: 03/04/2018
• Device Catalogue Number: 10144
• Device Lot Number: 17B086
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: Not provided; 07/27/2017
• Supplement Dates FDA Received: 06/27/2017; 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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