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

Catalog Number 10104-003

Device Problems Improper or Incorrect Procedure or Method (2017); Chemical Problem (2893); Device Handling Problem (3265)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a female health care worker (hcw) experienced a second degree chemical burn on her right hand thumb when she touched a tyvek® self-seal pouch that had been processed in three consecutive sterrad® 100nx cycles.The hcw was wearing gloves when she initially removed the tyvek® self-seal pouch from the sterilizer and placed the tyvek® self-seal pouch on a rack prior to putting it away.She later removed her gloves and picked up the same tyvek® self-seal pouch to put it away, and then experienced a burn on her right thumb.She washed the affected area and the skin started to ¿bubble like a blister¿.The hcw was treated in the emergency room with bacitracin ointment, vaseline gauze and a kling dressing.She also received follow-up at a burn center, where she continued with the same topical treatment and was instructed not to lift anything.The affected area measured a little bit bigger than the size of a quarter, and the white area peeled off in approximately five days.The hcw reported the skin completely healed, but is still very sensitive to touch.The topical treatment was discontinued and the hcw returned to work on (b)(6) 2017 and at that time she said she was doing ¿fine." service was not dispatched for the sterrad® 100nx since the customer acknowledged user error as the cause of the h2o2 reaction.The hcw stated they had incorrectly placed the tyvek® self-seal pouch on the top shelf of the chamber making it difficult to see which lead to them leaving it in for two additional cycles.She stated she did not notice any abnormalities when removing the tyvek® self-seal pouch from the unit nor did she notice any residual h2o2 on the tyvek® self-seal pouch when she touched it.The customer was advised to always wear personal protective equipment (ppe) when handling any processed items.Based on the information contained in the complaint at the time the reporting determination was made, this complaint is deemed reportable as a serious injury.The hcw experienced a second degree burn and received medical treatment.Although there were no reported product malfunctions, this event was related to ¿user error¿ which resulted in a serious injury.This is one of two 3500a reports being submitted for this serious injury involving two asp products.Please reference manufacturer report numbers: 2084725-2017-00679 & 2084725-2017-00680.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the residen/procedure related issue and system risk analysis (sra).The dhr was not reviewed since user error was determined to be the cause of the issue.Trending analysis of the procedure related and residue issue was reviewed from (b)(6) 2017 to (b)(6) 2017 and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "medium." the assignable cause of the issue is due to user error.The customer processed a load three consecutive times on the top shelf without realizing the load had been left in the chamber and the customer handled the load without wearing personal protective equipment (ppe).The asp fse re-trained the staff on proper handling of loads and sterrad use.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.(b)(4).

• Brand Name: STERRAD® 100NX STERILIZER
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 7132248
• MDR Text Key: 95318199
• Report Number: 2084725-2017-00679
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• PMA/PMN Number: K163598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10104-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/02/2018
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1