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

Catalog Number 14202

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

Event Description

A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle and the affected load was released for use on patients prior to reprocessing.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.

Manufacturer Narrative

H3: asp investigation summary: the investigation included a review of the device history record (dhr), complaint trending by lot number, system risk analysis (sra), visual analysis and concomitant product evaluation.Dhr was not performed as the lot number was not available.Complaint trending by lot number was not performed since the lot number was not available.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." an asp field service engineer (fse) was dispatched to the site and ran a test cycle on the sterrad 100s sterilizer and was unable to duplicate the issue.The cycle completed successfully and no problem could be found.The ci tape was not available for return; therefore, no visual analysis could be performed.The assignable cause of the issue could not be determined as there is insufficient information provided by the customer to determine the cause.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD SEALSURE CI TAPE
• Type of Device: INDICATOR, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10836858
• MDR Text Key: 217697349
• Report Number: 2084725-2020-50273
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 20705037016201
• UDI-Public: 20705037016201
• Combination Product (y/n): N
• PMA/PMN Number: 122331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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 Catalogue Number: 14202
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1