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 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

Ni.

Event Description

An international customer reported a healthcare worker (hcw) tried to re-insert a sterrad® 100nx cassette after it was ejected and came in contact with hydrogen peroxide (h2o2) from the cassette.The hcw was wearing personal protective equipment (ppe) but the h2o2 contacted his/her upper arm.The affected site turned red the hcw sought medical treatment.The hcw was given an unknown ointment and was instructed to apply it for seven days.The hcw has recovered.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Method code: microscopic inspection.Conclusion: no failure detected, device out of specification.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of the product malfunction codes and lot number, system risk analysis (sra) and return product evaluation: the dhr was reviewed and leaking cellblocks were detected during manufacturing, for which non-conformance was initiated for further investigation.Trending analysis for suspect positive bi by lot number involved was reviewed from 05/09/2015 to 11/05/2015 for product malfunction codes 'fluid leak' and 'skin/bone reaction' and trending was not exceeded.The suspect device was returned for evaluation.The reported event of leakage was confirmed.However, the nature of the leakage is uncharacteristic of manufacturing process.An inspection via a light microscope showed a rupture at the tip by the piercing zone with a smooth cutting surface in cell 4 close to the piercing zone.This kind of defect with some plastic sticking away from the cellblock cutting surface indicates that the damage was most likely caused by external impact after production.During the manufacturing process, the cellblocks are inspected visually and tested 100% in the vacuum chamber.All boxes used for internal transport of cellblocks are laid out with indicator paper to detect a possible leakage.The leakage caused by such damaged cells would have likely been noticed during manufacturing processes.The sra indicates the risk associated with the reported event is low with exposure to toxic or corrosive material and skin/bone reaction as 'moderate.' a field service engineer (fse) visited the site and found the unit involved to meet specifications.Fse also consulted/confirmed with the customer method for cassette insertion.A definitive assignable cause for the reported event is inconclusive.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
• MDR Report Key: 5234128
• MDR Text Key: 31570805
• Report Number: 2084725-2015-00549
• 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: 10/27/2015

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: 08/14/2016
• Device Catalogue Number: 10144
• Device Lot Number: 15H067
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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