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

Catalog Number 10144

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

Patient Problem Skin Irritation (2076)

Event Date 06/27/2019

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) experienced a skin reaction after re-inserting a sterrad® 100nx cassette into their sterrad® 100nx sterilizer after the cycle cancelled.The thumb and index finger of the hcw turned white.The hcw washed the affected area under water, and the skin reaction resolved after 30 minutes without medical treatment.The hcw was not wearing personal protective equipment at the time of the event.Advanced sterilization products has requested additional information but has received nothing further to date.There are no serious injuries reported in this complaint, and the h2o2 skin reaction resolved after washing and without medical treatment.Furthermore, 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.However, this skin reaction was due to contact with h2o2 from a sterrad® 100nx cassette.Therefore, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the batch history record, complaint trending by lot number, and system risk analysis (sra).A batch history record review was not performed since the lot number was not available.Trending analysis by lot number was not reviewed as the lot number was not available.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." visual analysis was not performed as the product was not available for return.The likely assignable cause of this issue was failure to follow the instructions for use.The customer handled a cassette without adequate personal protective equipment (ppe).The customer will be advised to always wear gloves when handling cassettes.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CASSETTE, 100 NX
• Type of Device: STERRAD® 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8780637
• MDR Text Key: 150716204
• Report Number: 2084725-2019-00903
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1