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

Catalog Number 10144

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

Patient Problem Skin Irritation (2076)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a female health care worker (hcw) came in contact with h2o2 while opening a new sterrad 100nx cassette.The hcw was not wearing personal protective equipment (ppe), and her arms and hands turned white.She washed the affected area and the symptoms resolved within 1-2 hours.No medical attention was sought and the healthcare worker is reported to be fine.There are no serious injuries reported in this complaint, and the h2o2 skin reaction resolved after washing and without medical treatment.Furthermore, there is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure.However, this skin reaction was due to contact with h2o2 from a leaking sterrad 100nx cassette; therefore, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the dhr/device batch record, supplier product evaluation, trending of the lot number, and system risk analysis (sra).The dhr/batch record was not reviewed as the lot number of the cassette was not available.Supplier product evaluation was not performed as the cause of the reported issue is user error.In addition, the suspect product was not returned for evaluation.Complaint trending of the lot number was not reviewed since the lot was not available.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." the issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).The customer was advised to always wear proper ppe to avoid this issue in the future.The issue was resolved at the customer site.The issue will continue to be tracked and trended.

• Brand Name: STERRAD®100NX CASSETTE
• 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: 7051245
• MDR Text Key: 93247278
• Report Number: 2084725-2017-00657
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071345
• 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: 10/26/2017

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 Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 12/23/2017
• Supplement Dates FDA Received: 12/26/2017
• 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