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

Catalog Number 10144

Device Problems Chemical Problem (2893); Device Handling Problem (3265)

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

A customer reported a healthcare worker (hcw) had a skin reaction on their hand after opening a brand new sterrad® 100nx cassette from its packaging.The symptoms included pain and redness at the site and reported the redness decreased later that same evening the event occurred.It is unknown if the healthcare worker was wearing personal protective equipment (ppe) while handling the cassette.Asp requested additional information regarding the event but has received nothing further to date.The limited information suggests the h2o2 skin reaction was not serious and the redness decreased that same evening.In addition, 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

The investigation included a review of the device batch record, supplier product evaluation, trending analysis of the lot number, and system risk analysis (sra).The batch record was not reviewed as the lot number of the cassette was not available.Supplier product evaluation was performed.An empty foil packaging was received.The foil wrapping per specification does not bear the lot number.The indicator bar was completely white, and there was no moisture and/or smell of h202 not any sign that the absorbent gel would have contact with the liquid.The complaint cannot be confirmed.Trending analysis by lot number was not performed as the lot number was not available.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the assignable cause of the issue could not be verified.The customer handled the cassette without personal protective equipment (ppe) but reported that the leak indicator was white, indicating no leak.Additionally, the customer was unable to confirm if any moisture or leakage was present on the cassette.The field sample was returned for investigation and the indicator bar was completely white, and there was no moisture and/or smell of h2o2, nor any sign that the absorbent gel would have had contact with a liquid.The customer will be reminded to follow the cassette instructions for use (ifu) and to always wear ppe when handling a used cassette or any of the cassette case components that may have been subject to a liquid leak.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

Manufacturer Narrative

Upon follow-up with the customer, it was confirmed on the healthcare worker was not wearing personal protective equipment (ppe) while opening a brand new sterrad 100nx cassette from its packaging.The affected area turned white and the hcw felt a prickle feeling.The skin reaction resolved after washing the area with water and without any medical attention.Concomitant medical product: device available for evaluation correction from no to yes.Device evaluated by manufacturer correction from not returned to manufacturer to no.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® CASSETTE, 100 NX
• Type of Device: STERRAD® 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8529639
• MDR Text Key: 142496087
• Report Number: 2084725-2019-00865
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD® 100NX STERILIZER, (B)(4).