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

Catalog Number 10144

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Skin Irritation (2076)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a customer, a female health care worker (hcw) came in contact with h2o2 residue when handling a used, leaking sterrad 100nx cassette.The hcw was wearing gloves, but the glove was ripped.It was reported a ¿tiny portion on her hand that turned white¿ and she washed her hands immediately four times.Per policy, the hcw went to employee health, but she did not receive any medical treatment and she did not miss any work.It was stated¿ ¿she was perfectly fine¿ and ¿nothing was really wrong¿ and the small white spot lasted less than a day.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, trending of the lot number, concomitant product evaluation 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 not performed as the customer discarded the cassette.Trending by lot number was not reviewed as the cassette was discarded by the customer and the lot number was unavailable.The concomitant sterrad was evaluated and corrective maintenance was performed.It is unclear whether or not the service performed is related to the leaking cassette issue.The sra indicates the risk associated with improper handling of a cassette is "low." after the event occurred, it was reported, the spd manager re-trained all staff about the proper use of wearing personal protective equipment (ppe).In addition, the facilities technician will be installing a shelf right next to the sterrad unit to keep glove boxes readily available.The issue has been attributed the healthcare worker (hcw) handling a used cassette wearing ppe that was ripped or torn.The customer self-identified and re-trained the staff.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: 7008185
• MDR Text Key: 92314815
• Report Number: 2084725-2017-00647
• 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: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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
• Date Manufacturer Received: 12/14/2017
• 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