MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® SEALSURE CI TAPE; INDICATOR, CHEMICAL

Catalog Number 14202

Device Problem Chemical Problem (2893)

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

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record, trending analysis by lot number, system risk analysis (sra) and supplier product investigation.The device history record was reviewed and process specifications for product release were met.No issues were observed that would contribute to the complaint.Trending analysis by lot number was reviewed from 2/6/2018 to 8/6/2018 and no significant trend was observed.The sra indicates the risk associated with exposure to toxic or corrosive material is "low".One sterrad® sealsure ci tape retains of the same lot was subject to functional investigation by the supplier.A sterilization test was performed and the color of the ci tape changed normally from red to yellow.The assignable cause of the issue could not be confirmed; however, a likely cause could be due to the customer's load contents as subsequent use of the sealsure chemical indicator tape provided acceptable results according to the customer.Also, the supplier could not replicate the issue with the retain sample.The customer will be retrained to follow the ifu which states: "if after processing, the color of the indicator is not equivalent to or lighter than the comparator bar shown in this instructions for use label, reject the cycle and resterilize all items.".The issue will continue to be tracked and trended.(b)(6).Asp complaint ref #: (b)(4).

Event Description

A customer initially reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle.At the time of the report, it was unknown whether or not the affected load was released for use on patients prior to reprocessing.Upon follow-up with the customer on (b)(6) 2019, it was determined the load was released for use without reprocessing first.There is no report of infection, injury or harm to patient(s) associated with this issue.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of sterrad® sealsure chemical indicator tape not changing color correctly when the load is released for use without reprocessing first.

• Brand Name: STERRAD® SEALSURE CI TAPE
• Type of Device: INDICATOR, CHEMICAL
• 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: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8466848
• MDR Text Key: 140453666
• Report Number: 2084725-2019-00851
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016204
• UDI-Public: 10705037016204
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: 122331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2019

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: 11/26/2019
• Device Catalogue Number: 14202
• Device Lot Number: 02618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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