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 Patient Involvement (2645)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® sealsure chemical indicator tape.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14202.

Event Description

A customer reported the sterrad® sealsure chemical indicator tape changed color "irregularly" after a completed sterrad® 100nx cycle.The affected load was reprocessed.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

No anomalies were observed in the dhr that would contribute to the customer's experienced issue.Two rolls of unused sealsure tape were received.The color and the condition of the rolls were within the specification.The customer did not send the faulty part of the tape for evaluations.

Manufacturer Narrative

Correction: one roll of unused sealsure tape was received.Correction method code: the correct value is (b)(4), not (b)(4).

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), complaint trending analysis, visual analysis and system risk analysis (sra).Complaint trending by lot number was reviewed from 06/08/2016 to 12/05/2016 and no significant trend was observed.Retains testing was performed and no anomalies were found with the lot.The sra indicates the risk associated with a quality problem with no impact on safety is "low." there is insufficient information to determine an assignable cause as the dhr and retains testing by lot found no anomalies that would contribute to the issue.In addition, the customer returned the unused portion of the ci tape but did to return the portion that was used.If additional information becomes available, the file will be re-opened and evaluated.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: 6207753
• MDR Text Key: 63371038
• Report Number: 2084725-2016-00791
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup,Followup
• Report Date: 12/02/2016

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: 09/30/2016
• Device Catalogue Number: 14324
• Device Lot Number: 02016
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2017; 03/13/2017; 03/29/2017; 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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