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

Catalog Number 10144

Device Problem Use of Device Problem (1670)

Patient Problems Skin Discoloration (2074); Skin Burning Sensation (4540)

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone number:(b)(6).The batch record review did not reveal any indication on a deviating quality profile for this batch.All in-process controls corresponded to the specification.The customer facility will be retrained on the proper handling of used cassette.Per the sterrad® 100nx user's guide: ¿for safety reasons, you must use the cassette disposal box to dispose of cassettes.Never reuse a cassette disposal box.Once a cassette disposal box has been removed, a new cassette disposal box must be inserted.¿ this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).

Event Description

A customer reported a health care worker (hcw) experienced a skin reaction from discarding a used sterrad® 100nx cassette by removing the cassette from the disposal collection box.The hcw was not wearing gloves and made contact with h2o2 on the left hand, palm and fingers.The hcw suffered a skin burning sensation and a white skin discoloration, and the affected area was immediately washed with water.The hcw visited emergency assistance per occupational accident protocol, where the affected area was further rinsed with water and vaseline gauze was applied to the ¿burning¿ area.The skin reaction lasted six hours, and the hcw was reported as being ¿well¿ and ¿operating smoothly¿.The injuries were assessed to be minor since the h2o2 skin reaction resolved with first-aid minimal intervention; however, this event is being reported as a malfunction report subsequent to a previous serious injury due to contact with h2o2 from a sterrad 100nx cassette.

Manufacturer Narrative

Asp investigation summary: the batch record review did not reveal any indication on a deviating quality profile for this batch.Trending analysis by lot number was reviewed for the six months prior to open date and trending was not exceeded.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low.".The suspect sterrad® 100nx cassette was discarded and not available for evaluation.Additionally, user error associated with the event was identified; therefore, no supplier investigation was performed.The most likely assignable cause for the skin reaction can be attributed to user not following the sterrad® 100nx user guide for proper handling of cassettes.The hcw was retrained to always wear appropriate personal protective equipment (ppe) when working with sterrad systems.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• 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: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 17262543
• MDR Text Key: 319041243
• Report Number: 2084725-2023-00168
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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: 08/10/2023
• Device Catalogue Number: 10144
• Device Lot Number: 22J007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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