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

Catalog Number	10144-90
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Handling Problem (3265)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hcw was re-trained to always wear gloves as per in the sterrad® 100nx cassette instructions for use: ¿use personal protective equipment (e.G.Chemical resistant gloves) at all times when handling cassettes¿.The batch history record was reviewed and no issues relating to the failure mode were noted.The involved batch met manufacturer specifications at the time of release.Visual inspection of the retain samples was performed, and the retain samples did not show any sign of leakage or change of color of the indicator strip.Visual inspection of field sample pictures was performed, and the pictures showed a cassette with the indicator bar having changed color to red and the label on the cassette not completely readable and smudged, which is a strong indication for leakage.It also appears that cell number 2 has emptied, and a small hole was observed; this defect could be triggered by external mechanical stress.Based on these pictures, the complaint was confirmed; however, a manufacturing issue could not be detected.The batch record review of semi-finished and finished product did not reveal any deviations or nonconformances that occurred during production and at the timepoint of product release.There is a 100% visual inspection of cellblocks, each cellblock to be packed individually must be visually inspected for discolored and/or bloated cells, no bad cellblocks were detected during this inspection.No leaking cellblocks were found during the production of the intermediate batch, all cellblocks passed a 100% visual inspection and 100% leak test in the vacuum chamber.All specifications were met, no issues or leaking cellblock were reported during these tests; therefore, although the complaint is confirmed, no manufacturing root cause could be identified.Asp complaint ref #: cmp-(b)(4).
Event or Problem Description
A customer reported a healthcare worker (hcw) experienced "cold burns" or skin reaction when she opened a new package of sterrad® 100nx cassette.The hcw was not wearing gloves when she made contact with hydrogen peroxide (h2o2) without noticing the chemical indicator strip had changed color to red, which indicates h2o2 leakage has occurred.The liquid adhered to her hand and affected an area on her palm measuring approximately 10 cm.She washed the affected area with water and visited a dermatologist, and the doctor noted the skin reaction as ¿minor¿ with no residual h2o2 present.The duration of the skin reaction lasted ¿half day¿ and the hcw status was updated to ¿no problem¿ due to appropriate measures were taken.The h2o2 skin reaction is considered not serious and resolved in half a day after washing the affected area.The dermatologist noted the injury to be ¿minor¿ and no medical or surgical intervention was required; however, this event is being reported as a malfunction subsequent to a previous serious injury.
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the batch record, trending analysis by lot number, system risk analysis (sra), retains testing, and visual analysis.Retains testing was completed with no issues identified; the retain samples were within specifications.Trending analysis by lot number was reviewed from the manufactured date to the event date, and no significant trend was observed.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the suspect sterrad® 100nx cassette was not returned for evaluation.The assignable cause for the cassette leak could not be verified.The supplier product investigation did not reveal any anomalies related to this failure mode, and all manufacturing in-process controls corresponded to specifications.The most likely assignable cause for the skin reaction can be attributed to user not wearing appropriate personal protective equipment and not following warnings as per the sterrad® 100nx cassette instructions for use, which states, ¿warning: do not open the protective plastic wrapper if the leak indicator strip indicates a leak.If a leak is indicated, then the cassette might have been damaged.¿ asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Common Device Name: 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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 13764996
• Report Number: 2084725-2022-00057
• Device Sequence Number: 12027747
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• PMA/510(K) Number: K071345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2022
• Device Catalogue Number: 10144-90
• Device Lot Number: 21K019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown