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 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® chemical indicator strip.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14100.

Event Description

A customer reported a sterrad® chemical indicator strip presented color change several days after processing.The status of the load is unknown; however, there was no report of infection, injury or harm to patient(s) associated with this issue.Asp will continue to follow up for additional information.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® chemical indicator strips not changing color correctly.

Manufacturer Narrative

Additional information was received that the color of the chemical indicator had changed correctly immediately and within specification after processing in the unit.As such the color of the chemical indicator changed correctly, this event is no longer deemed a reportable event.

• 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: 6214781
• MDR Text Key: 63618779
• Report Number: 2084725-2016-00801
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

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: 04/30/2017
• Device Catalogue Number: 14324
• Device Lot Number: 278511-04
• Other Device ID Number: 14324
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2017
• Date Device Manufactured: 10/01/2015
• 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