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

Catalog Number 10144

Device Problems Chemical Problem (2893); Device Handling Problem (3265)

Patient Problem Skin Irritation (2076)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Ni.

Event Description

A healthcare worker (hcw) reported feeling an "intense burning" on her finger while removing a sterrad 100nx cassette from the sterrad sterilizer.The hcw was not wearing personal protective equipment and the affected area was washed with soap and water to resolve her symptoms.The symptoms lasted one day and the hcw is reported to be in "good health".This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Change catalog # from 10144 to 10133.Additional clarification was received stating the cassette issue involved a sterrad® nx cassette and not a sterrad® 100nx cassette as initially reported.This event did not cause any serious injury and there have been no subsequent serious injuries associated with a sterrad® nx cassette.Therefore, this complaint file is deemed not reportable.

• 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: 6023233
• MDR Text Key: 57265152
• Report Number: 2084725-2016-00600
• 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: 09/16/2016

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 Expiration Date: 05/30/2017
• Device Catalogue Number: 10144
• Device Lot Number: 16F018
• Other Device ID Number: 10144
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• 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