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

Catalog Number 14324

Device Problems Device Operates Differently Than Expected (2913); Environmental Particulates (2930)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2017

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® nx cycle.The affected load was reprocessed.There was 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.(b)(4).This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2017-00108 and 2084725-2017-00109.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, visual analysis, retains testing and system risk analysis (sra).The dhr, trending analysis by lot number, visual analysis and retains testing was not reviewed since there is clear evidence that user error was determined to be the cause of the issue.The sra indicates the risk associated with a quality problem with no impact on safety is "low." the concomitant sterrad® nx was tested by a field service engineer.The unit was in working condition and no maintenance was required.The assignable cause of the issue can be attributed to user error as the customer indicated they had placed towels in the affected load.Per the instructions for use (ifu), it states that any materials that would absorb liquids, such as cellulose, cotton, paper or cardboard, linens, and towels should not be processed in the unit.The customer was advised of proper load preparation.The issue will continue to be tracked and trended.

• 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: 6375021
• MDR Text Key: 68978272
• Report Number: 2084725-2017-00109
• 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: 02/10/2017

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: 14324
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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