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

Catalog Number 10144

Device Problem Chemical Spillage (2894)

Patient Problem Skin Irritation (2076)

Event Date 08/27/2016

Event Type  malfunction  

Manufacturer Narrative

Ni.

Event Description

A customer reported a healthcare worker (hcw) burned their hand while removing a sterrad 100nx cassette from their sterrad sterilizer.Specific details regarding the incident are not known at this time.This event is being reported as a malfunction report subsequent to a serious injury.Asp will continue to follow up for additional information.

Manufacturer Narrative

New information reports this (b)(6) old, male hcw made contact with h2o2 on his finger when he received and touched a package, which had ¿liquid observed on the package¿.The hcw was not wearing ppe.He rinsed/flushed the affected area for 15 minutes.The skin reaction lasted 30 minutes, and the hcw reported the irritation disappeared.No medical attention or treatment was received.At the time the reporting determination was originally made, this h2o2 skin reaction was possibly due to the hcw touching a sterrad 100nx cassette; therefore, this event was reported as a malfunction subsequent to a serious injury.This new information reports the hcw did not touch a sterrad cassette, but instead touched moisture on a load which had been processed in the sterrad 100nx.Based on the new information received, this complaint is now deemed not reportable.The h2o2 skin reaction was not serious, and the symptoms resolved after standard rinsing.There is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure.

• 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: 5975527
• MDR Text Key: 55566420
• Report Number: 2084725-2016-00566
• 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: 08/29/2016

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
• Device Lot Number: 16C111
• Other Device ID Number: 10144
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• 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