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

Catalog Number 14202

Device Problem Chemical Problem (2893)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant med products: sterrad® 100s sterilizer, serial # (b)(4).(b)(6).(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.The affiliate did confirm, however, that the ci on the biological indicator changed correctly.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

Patient codes correction from 2692 to 2199.New information reported in a 3500a supplemental report on 8/22/2019 indicated the load was reprocessed prior to being released for use on patients which makes this event no longer a reportable malfunction since there is no longer any risk to patients.Asp complaint ref #: (b)(4).

Manufacturer Narrative

It was originally reported in the initial report that the load was released for use on patients without reprocessing first.Upon follow-up, the customer confirmed the load was reprocessed prior to being released for use for use on patients.The customer confirmed the ci tape was not overlapping and the load was not over packed.Asp complaint ref #: (b)(4).

• Brand Name: SEALSURE CI TAPE CASE
• Type of Device: INDICATOR, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8839629
• MDR Text Key: 158894155
• Report Number: 2084725-2019-00916
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037016204
• UDI-Public: 10705037016204
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2019

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 Catalogue Number: 14202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 07/30/2019; 09/26/2019
• Supplement Dates FDA Received: 08/22/2019; 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1