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 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

Asp complaint # pc-(b)(4).The batch record review did not reveal any indication on a deviating quality profile for this batch.No anomalies were observed that would contribute to the customer's experienced issue.All in-process controls corresponded to the specification.

Event Description

The customer reported a healthcare worker (hcw) had a sustained hydrogen peroxide burns to both hands on the pointer and index fingers of the right hand and on the pointer finger of the left hand.The incident occurred after opening/unwrapping a new sterrad®100nx cassette without wearing personal protective equipment.The hcw reported checking chemical indicator located inside the packaging prior to opening the package and there were no signs of color change or indication of h2o2 leakage.Upon noticing "white patches" on the skin the hcw washed her hands immediately with tap water, and reported the skin on both hands remained intact and there was ¿no discomfort." lastly, there is no report of medical attention or treatment.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Advanced sterilization products requested and received the h2o2 contact worksheet, which confirmed the event happened when the hcw was changing the cassette.Two open cassettes of lot 17e077 were received.One cassette was used (the first six cells were punctured and empty).The cassette does not present with any defect.This is believed to be one of the cassettes being reported as having worked normal and was in the disposal box.The second cassette appears unused, however, cell #3 shows only approx.1/3 of the content of liquid.This is suspected to be the cassette related to the leakage complaint.The cassette was given to production for investigation.It was found to have a leaking hole at the piercing zone of cell 3 was found.The size of damage/ hole is 0.5mm.The hole must have been caused by a heavy mechanical impact at this area of the cell.Such a defect of the cell wall cannot occur during the manufacturing process or packaging.Furthermore, such a cellblock cannot leave the production as there is a 100% visual inspection of cellblocks and 100% check (vacuum test) for leakages.While the defect can be confirmed it is highly unlikely that such a defect occurred during production or packaging.

Manufacturer Narrative

(b)(6).Asp investigation summary: the investigation included a review of the batch record, lot trending, functional analysis and system risk analysis (sra).Trending analysis by lot number was reviewed from 03/15/2017 to 09/11/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the most likely cause of the complaint issue was use error caused by handling a leaking cassette without wearing personal protective equipment (ppe).The customer stated they were in a hurry so they did not handle the cassette with ppe as they should have.The customer was reminded 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 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: 6908354
• MDR Text Key: 89412489
• Report Number: 2084725-2017-00592
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2018
• Device Catalogue Number: 10144
• Device Lot Number: 17E077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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