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 Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 did not change color correctly after a completed sterrad® 100nx duo 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

Change from ¿it is unknown if the affected load was recalled or released for use¿ to ¿the affected load was reprocessed.¿ (b)(4).

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

Corrected data: expiration date: the correct date is 12/19/2017.Asp investigation summary: the investigation included a review of the device history record (dhr), trend of lot number, system risk analysis (sra), product return, concomitant product evaluation and retains analysis.Trending analysis by lot number was reviewed from 06/11/2016 to 12/08/2016 and trending was not exceeded.Retain evaluation/testing was performed by the sealsure chemical indicator (ci) tape supplier, (b)(4).The supplier sterilized a retain sample from the same lot number (05016) and did not find any anomalies.Therefore, the root cause of the reported problem could not be determined.A field service engineer (fse) visited the customer site to assess the concomitant sterrad 100nx unit involved in this complaint.The fse found that the color changed irregularly when the chemical indicator (ci) was put on surface of the sterilization bag.The other chemical indicators changed correctly.Therefore, no service was performed as there was no reported issue with the sterrad® 100nx unit and the issue was identified as a chemical indicator issue.The sra indicates the risk associated with hazard of 'quality problem with no impact on safety is "low." there is insufficient information to determine the cause or resolution of the color-chemical indicator issue.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: 6207764
• MDR Text Key: 63369231
• Report Number: 2084725-2016-00793
• 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: 12/19/2017
• Device Catalogue Number: 14324
• Device Lot Number: 05016
• 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: 01/18/2017; 02/10/2017; 03/13/2017; 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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