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

Catalog Number 10144

Device Problems Chemical Spillage (2894); Device Handling Problem (3265)

Patient Problem Skin Irritation (2076)

Event Date 06/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by an advanced sterilization products representative, a female health care worker (hcw) experienced a skin reaction when she was exposed to h2o2 from a leaking sterrad 100nx cassette.The chemical indicator strip inside the cassette packaging was white and did not turn red.The hcw removed the clear wrapping of the cassette without gloves, and four fingers on her left hand turned white.She rinsed the affected area with water for about 15 minutes, and the skin reaction lasted two hours.She did not require medical treatment or prescriptions, and her current status is ¿cleared¿.There are no serious injuries reported in this complaint, however, this h2o2 skin reaction was due to the hcw touching a leaking sterrad 100nx cassette; therefore, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Patient identifier correction from na to unk.Asp investigation summary: the investigation included a review of the device batch record, lot trending, and system risk analysis (sra).The batch record was reviewed by the supplier and did not indicate a deviating quality profile for this batch.No events or deviations were reported that could relate to this complaint issue.All in-process controls corresponded to specifications.Trending analysis by lot number for the issue of cassette leak: human contact was reviewed from 12/26/2016 to 06/24/2017 and trending was not exceeded.Trending analysis by lot number for the issue of cassette leak: indicator strip is white was reviewed from 12/26/2016 to 06/24/2017 and trending was not exceeded.The sra for the issue of cassette leak: human contact indicates the risk associated with exposure to toxic or corrosive material is "low." the sra for the issue of cassette leak: indicator strip is white indicates the risk associated with exposure to toxic or corrosive material is "low." the cassette was not available for return and further analysis.The assignable cause of the leaking cassette and the indicator not changing color could not be verified as the cassette was not available for return, batch history record found no anomalies that would contribute to the issue, and lot history review did not exceed trending.However, the human reaction has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe) while handling the cassette.The customer will be sent a letter advising to wear personal protective equipment (ppe) while handling cassettes and and to always follow the instructions for use (ifu).The issue will continue to be tracked and trended.Asp complaint ref #: (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: 6734703
• MDR Text Key: 80758139
• Report Number: 2084725-2017-00519
• Device Sequence Number: 1
• Product Code: MLR
• 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,Followup
• Report Date: 06/24/2017

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: 01/25/2018
• Device Catalogue Number: 10144
• Device Lot Number: 17A068
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 11/03/2017; 07/11/2018
• Supplement Dates FDA Received: 11/28/2017; 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1