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 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Asp complaint ref #: (b)(4).

Event Description

A customer reported a healthcare worker (hcw) received a skin reaction on his/her hand after contact with h2o2 from a leaking sterrad® 100nx cassette while removing the packaging.The chemical indicator on the new cassette was discolor prior to use and the hcw touched it by mistake.The affected area turned white, and the hcw washed with running water.It was reported the skin reaction healed without any medical attention.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

Device available for evaluation correction from no to yes.Device evaluated by manufacturer correction from not returned to manufacturer to yes.Asp investigation summary: the investigation included a review of the device batch record, lot trending, system risk analysis (sra) and functional analysis.¿the batch record review did not reveal any indication on a deviating quality profile for this batch.No quality issues were reported.All in-process controls corresponded to the specification.¿ trending analysis by lot number was reviewed from 03/10/2018 to 09/06/2018 and trending was not exceeded.¿the sra shows the risk for exposure to toxic or corrosive material to be "low." one 100nx sterrad cassette was returned for evaluation and functional analysis.The cassette was opened and observed to be completely soaked with h2o2.The indicator stripe turned red over its whole length.No further investigation is performed on this cassette for safety reasons.The cassette leak is confirmed.The issue has been attributed to user error as the healthcare worker (hcw) was not using proper personal protective equipment (ppe).The chemical indicator on the cassette had changed to red indicating hydrogen peroxide exposure.The customer was advised to check the color of the chemical indicator and to wear personal protective equipment (ppe) when handling cassettes.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7871298
• MDR Text Key: 120099512
• Report Number: 2084725-2018-00709
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2019
• Device Catalogue Number: 10144
• Device Lot Number: 18C051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1