MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL (FRC)

Catalog Number 14324

Device Problems Chemical Problem (2893); Device Operates Differently Than Expected (2913)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

The correct brand name is sterrad® sealsure chemical indicator tape.The correct common device is indicator, chemical.The correct catalog number is 14202.

Event Description

A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100's cycle.It is unknown if the affected load was recalled or released for use.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

Upon follow-up with the customer, they confirmed the issue was not an issue with the sealsure tape, but that the sterrad cycle cancelled.Therefore, this is not considered a reportable event since the cycle cancelled and there was no suspected issue with the sealsure tape.

• Brand Name: STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• 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: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6571517
• MDR Text Key: 75308840
• Report Number: 2084725-2017-00243
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14324
• Device Lot Number: 28016
• Other Device ID Number: 14324
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1