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 did not change color correctly 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

Two rolls of unused sealsure tape 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.The complaint can not be confirmed.The supplier performed retain testing on the same lot and did not find any anomalies.The supplier's review of the batch history review found no anomalies were observed that would contribute to the customer's experienced issue.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trend of lot number, system risk analysis (sra), product return evaluation, 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.The sra indicates the risk associated with a quality problem with no impact on safety is "low" risk.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.There was no reported issue with the sterrad®100nx unit and no corrective maintenance was required to be performed on the unit, therefore a unit issue is unlikely.Dhr, retains and returned product evaluation found no problem with product manufacturing and a problem with the sterrad®100nx unit is unlikely.The complaint product was not returned by the customer therefore product return evaluation could not be performed and additional information about the event is unavailable.As such, insufficient information is available to determine the assignable cause for the color-chemical indicator issue.If additional information is made available later, the complaint will be re-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: 6207733
• MDR Text Key: 63371855
• Report Number: 2084725-2016-00790
• 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
• 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: 08/21/2017
• Device Catalogue Number: 14324
• Device Lot Number: 29415
• 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
• Supplement Dates FDA Received: 02/10/2017; 03/24/2017; 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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