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

Catalog Number 10144

Device Problem Chemical Problem (2893)

Patient Problem Skin Irritation (2076)

Event Date 02/19/2014

Event Type  Injury  

Manufacturer Narrative

Ni.

Event Description

An international customer reported a healthcare worker (hcw) "picked up a used sterrad 100nx sterilizer cassette to discard it rather than leaving it in the cassette collection box" and as a result sustained whitening of the skin on her palm, arm and wrist.She was not wearing ppe.The hcw rinsed the affected area for 15 minutes and visited the emergency department for assessment.The hcw was diagnosed with a hydrogen peroxide burn and a dressing was applied to her hand.The hcw was told to return the next day for a change of dressing and given three days off work.The hcw has recovered and is back to work.This complaint is being reported to fda as a serious injury report for symptoms related to the hydrogen peroxide contact.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, health hazard evaluation (hhe) and system hazard and user misuse analysis (shuma).The dhr was not reviewed as the lot number of the cassette was not available.The service history for 'unk" [ i.E unknown lot numbers in (b)(6)] for the past six months (08/24/2013 to 02/20/2014) did not identify any significant trend.The trend for the product malfunction code of skin reaction was assessed from march of 2013 through february of 2014.The risk is considered 'as low as reasonably practicable'.The hhe for contact with h2o2 from a sterrad® 100nx cassette assessed the risk of the issue as temporary or reversible, and the product problem has been known to result in the identified harm, but only occasionally and/or under unusual circumstances.The shuma indicates the risk is broadly acceptable.There was no product returned.Testing is not required as the issue is considered to be user error.The assignable cause is that the customer did not follow the product's ifu to wear ppe when handling a used cassette.The customer was educated to use proper ppe when handling used cassettes.The healthcare worker returned to work.The reason for leave from work is unknown.

Event Description

Correction: this complaint is being reported to fda as a serious injury report because the healthcare worker was given three days off work related to symptoms of hydrogen peroxide contact.

• 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: ginny stamberger ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 3686946
• MDR Text Key: 19324164
• Report Number: 2084725-2014-00101
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2014

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: 10144
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 03/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 45 YR