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 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a female health care worker (hcw) felt some irritation and observed a bright white color on her finger after touching a used sterrad® 100nx cassette.The cassette was fully used and previously disposed from the unit, and the hcw was not wearing protective gloves.The hcw rinsed her hands under water.No medical attention was sought.The white color on the finger lasted only a few minutes.The information in the complaint suggests the h2o2 skin reaction was not serious and 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 used sterrad® 100nx cassette; therefore, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

The investigation included a review of the device batch record, lot trending, and system risk analysis (sra).Lot number is unavailable; therefore, dhr/batch record review could not be performed.Trending analysis by lot number was not reviewed since the lot number was not available.The sra indicates the risk associated with handling toxic or corrosive material is "low." no functional testing was performed as the cassette was discarded by the customer and not returned.The issue has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe).A customer letter was sent advising to always wear ppe while handling cassettes.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): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 7031645
• MDR Text Key: 92985402
• Report Number: 2084725-2017-00651
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• 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: Initial,Followup
• Report Date: 10/25/2017

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?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 01/23/2018
• 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