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

Catalog Number 10144

Device Problem Chemical Problem (2893)

Patient Problem No Code Available (3191)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).White color on fingers.

Event Description

An international customer reported hydrogen peroxide (h2o2) leakage inside the cover of a new and unused sterrad® 100nx cassette.White powder was discovered inside the packaging of this cassette.The chemical indicator did not change color as it should indicating a h2o2 leak.A hcw "got white color on their fingers but was not burned by the fluid h2o2 inside cassette." it is unknown if the hcw was wearing personal protective equipment (ppe).It is also unknown if the hcw received any medical attention/treatment.This event is being reported as a malfunction report subsequent to a serious injury.(b)(4) are related complaints from the same facility.This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2016-00131 and 2084725-2016-00132.

Manufacturer Narrative

No further information is known regarding the status of the hcw since the hcw is no longer is working at the facility.Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, lot trending, and system risk analysis (sra).Per the supplier, the batch record review did not indicate a deviating quality profile for this batch.No events or deviations were reported that could relate to this complaint issue.All in-process controls corresponded to specifications.Two cassettes were returned for evaluation.Both cellblocks were covered in a white, powdery residue confirming the report of white powder.All cells of both cassettes had the same volume.The indicators did not show any signs of discoloration.The filling level of all 10 cells was without any abnormalities and no leakages were detected.The indicator strip showed no discoloration by both received cassettes.Regarding contact with h2o2, the color of the indicator stripe changed to red as expected.The investigation of the packaging foil showed no abnormalities.Most likely the absorption flies had partially dissolved and spread within the foil as white particles.Lot history was reviewed from 8/15/2015 to 2/11/2016 and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the assignable cause could not be verified at this time as the supplier was unable to confirm the reported issue.Dissolution could have occurred during transport, but this cannot be verified.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: 5487806
• MDR Text Key: 39934966
• Report Number: 2084725-2016-00132
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 02/09/2016

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: 10/15/2016
• Device Catalogue Number: 10144
• Device Lot Number: 15JO52
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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