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

Catalog Number 10144

Device Problem Chemical Problem (2893)

Patient Problem Burn(s) (1757)

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

Ni.

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide while opening a new sterrad 100nx cassette.The cassette was reported to be broken and wet.The hcw was not wearing personal protective equipment (ppe) and "suffered burns" on her hands.The hcw flushed her hands with water and did not receive any additional treatment.The hcw is reported to be in "good health." this event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included device history record (dhr) review, trending analysis for this lot, and system risk analysis (sra): the dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer¿s experienced issue.Trending analysis for suspect positive bi by lot number involved was reviewed from 03/01/2015 to 08/28/2015 and trending was not exceeded for product malfunction codes 'leak' or 'skin reaction.' the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "limited." it is unlikely that there was a performance issue in the sterrad® cassette product since the batch record review found no anomalies that would contribute to the issue, and lot history review did not exceed trending.The product was not returned for analysis and could not be evaluated.The cause of the issue could not be verified.Training was provided to the staff on the use of ppe during handling of cassettes and the healthcare worker who experienced the burn was reported to be in healthy condition.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 ; irvine, CA 92618
• MDR Report Key: 5095574
• MDR Text Key: 26606220
• Report Number: 2084725-2015-00393
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/24/2015

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: 03/26/2016
• Device Catalogue Number: 10144
• Device Lot Number: 15D002
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1