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 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: sterrad® 100nx sterilizer, serial #: (b)(4).The batch record review did not reveal any indication on a deviating quality profile for this batch.No quality issues were reported.All in-process controls corresponded to the specification.Asp complaint ref #: (b)(4).

Event Description

A customer reported a health care worker (hcw) experienced a skin reaction on her fingers when she removed a sterrad® 100nx cassette from a sterrad® 100nx sterilizer.The hcw was not wearing gloves, and three of her fingers turned white.She washed with soap and water, and the skin reaction was gone within four hours.The hcw did not require medical attention and was reported to be fine.There are no serious injuries reported in this complaint, and the 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 complaint ref #: (b)(4).H3: asp investigation summary: the investigation included a review of the batch history record, complaint trending by lot number, and system risk analysis (sra).Trending analysis by lot number was reviewed for the previous six months from open date and no significant trend was observed.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 removed the cassette from the collection box without adequate personal protective equipment (ppe).The customer will be advised to always wear gloves when handling cassettes and reminded that the cassette disposal box should be used to dispose of cassettes and should not be reused.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
• MDR Report Key: 8741917
• MDR Text Key: 149495609
• Report Number: 2084725-2019-00893
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2020
• Device Catalogue Number: 10144
• Device Lot Number: 19A005
• 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