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

Catalog Number 10144

Device Problem Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

One open cassette was received.The indicator stripe of the open packaging partially shows a red color.None of the cells is punctured, but cell no.6 obviously shows a lower filling volume.Furthermore, the cassette appears to be slightly deformed.The dimensional measurements were within specifications.There was a hole detected at cell #6 at the area between the head and the main mold.Furthermore a deformation above the leaking cell was detected.There must have been a heavy mechanical impact at this area of the cell.Per the supplier, no anomalies were observed that would contribute to the customer's experienced issue.

Event Description

A customer reported a health care worker (hcw) noticed the color indicator on the sleeve of a brand new cassette was discolored.The customer felt "stickiness" when handling the sterrad® 100nx cassette.There was no report of infection, injury or harm to patient(s) associated with this issue.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 by lot number, and system risk analysis (sra).Trending analysis by lot number was reviewed from 09/02/2016 to 03/01/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the assignable cause of the issue could not be confirmed.Physical damage of the cell of the cassette was identified but it is unknown how the damage occurred.Although there was no contact with h2o2 from the cassette, the affiliate confirmed that the healthcare workers are trained on proper use of ppe while handling cassettes.The issue was resolved at the customer site.The issue will continue to be tracked and trended.

• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6432126
• MDR Text Key: 70799871
• Report Number: 2084725-2017-00154
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2017
• Device Catalogue Number: 10144
• Device Lot Number: 16L052
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1