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

Model Number 10144

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

Patient Problem Skin Irritation (2076)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant med products: sterrad® 100nx sterilizer, serial # (b)(4).Asp complaint ref #: (b)(4).

Event Description

A customer reported a healthcare worker (hcw) received a skin reaction while inserting a sterrad® 100nx cassette into the sterrad® 100nx sterilizer.The cassette was inadvertently inserted in the wrong direction and the sterrad® sterilizer rejected the cassette causing h202 to leak from the cassette.Although the hcw was wearing gloves, contact with h202 occurred on the hcw¿s arm.Details of the symptoms and duration of the skin reaction are not known; however, it was reported the hcw continued to work and later visited a dermatologist who prescribed an ointment.Advanced sterilization products requested further information but has received nothing further to date.The information contained in the complaint at the time the reporting determination was made suggests the h2o2 skin reaction was not serious.However, this skin reaction was due to contact with h2o2 from a sterrad 100nx cassette; therefore, this event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device batch record, trending analysis of the lot number, product evaluation and system risk analysis (sra).¿the batch record was not reviewed as the lot number of the cassette was not available.¿trending analysis by lot was not performed as the lot number of the cassette was not available.¿the sra indicates the risk associated with exposure to toxic or corrosive material to be "low." ¿the customer reported the cassette was discarded; therefore, no further evaluation could be performed.The assignable cause of the issue could not be verified but was likely due to improper insertion of the cassette into the sterrad sterilizer.The hcw was wearing gloves but it is unknown if the affected area on his arm was exposed.However, it was not reported that the hcw wore a gown.The customer has since been retrained regarding proper use of ppe.The issue will continue to be tracked and trended.Asp complaint ref # pc-(b)(4).

• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 10096696
• MDR Text Key: 196153253
• Report Number: 2084725-2020-00038
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014903
• UDI-Public: 10705037014903
• Combination Product (y/n): N
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10144
• Device Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1