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 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a healthcare worker (hcw) experienced a h2o2 skin reaction on their hands while disposing a used sterrad® 100nx cassette.The hcw was not wearing gloves, and the affected area turned white.The hcw washed with water and the skin reaction was gone within a few hours.No medical attention was sought and the hcw 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 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 device batch record, lot trending, system risk analysis (sra), retains testing, functional analysis and concomitant product evaluation.The device batch record was not able to be reviewed since the lot number of the cassette was not available.Trending analysis by lot number was not reviewed since the lot number was not available.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." retains testing was not performed since the lot number was not available.Functional analysis could not be performed since the customer stated the cassette was discarded.The concomitant sterrad was tested by an asp field service engineer and parts were replaced and the unit was confirmed to be within specifications after service.The issue has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe) while handling a used cassette.An asp clinician discussed with the customer the importance of always wearing ppe while handling cassette.The issue was resolved at the customer site.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7638535
• MDR Text Key: 112429581
• Report Number: 2084725-2018-00639
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014903
• UDI-Public: 10705037014903
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD® 100NX STERILIZER, SERIAL #: (B)(4)