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 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The batch record review did not reveal any indication on a deviating quality profile for this batch.There were no events or deviations that could relate to this complaint issue.All in-process controls corresponded to the specification.(b)(4).

Event Description

It was reported from (b)(6), a health care worker (hcw) experienced a skin reaction on his/her right index finger when he/she touched a used sterrad 100nx cassette in the collection box after a completed sterrad 100nx cycle.The hcw was not wearing personal protective equipment (ppe), and the affected area turned white and measured 2 cm in diameter.The hcw washed the area with running water and the affected area healed within one day without receiving medical attention.The information suggests the h2o2 skin reaction was not serious, and the affected area resolved after washing and without medical attention.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

Expiration date corrected from 3/25/2017 to 03/25/2018.Device manufacture date corrected from 3/30/2016 to 03/30/2017.Asp investigation summary: the investigation included a review of the batch history record, complaint trending, system risk analysis (sra) and functional analysis.Trending analysis for the issue of cassette leak human contact was reviewed from 12/21/2016 to 06/20/2017 and no significant trend was observed.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." functional analysis was not performed as the product was not available for return.The customer handled a cassette without adequate ppe which would be the most likely assignable cause for the skin reaction issue.An asp representative advised the customer to wear personal protective equipment while handling a cassette.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
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 6871403
• MDR Text Key: 87307060
• Report Number: 2084725-2017-00570
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2017
• Device Catalogue Number: 10144
• Device Lot Number: 17C051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1