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 12/01/2016

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.It is unknown if the affected load was released for use on patient(s); however, there were no reports of 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® sealsure chemical indicator tape not changing color correctly.

Manufacturer Narrative

There were no affected loads.(b)(4).Asp investigation summary: the investigation included a review of the certificate of conformance, product return, retain testing, lot history review, concomitant product evaluation and system risk analysis (sra).Per the certificate of conformance (c of c), the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.The sra indicates the risk associated with hazard of 'quality problem with no impact on safety is "low." trending analysis by lot number was reviewed from 06/04/2016 to 12/01/2016 and trending was not exceeded.Retain evaluation/testing was not performed since the chemical indicator (ci) tape changed color properly when an additional load was processed in another sterrad® unit.A field service engineer (fse) was dispatched to the customer site to assess the concomitant sterrad® nx unit involved in this complaint.The fse replaced the operator assembly, orifice and the valve, 3/8 dia, ran a successful test cycle and confirmed that the unit met specification.A visual inspection was not performed as no product was returned; therefore the reported issue was not confirmed.The sterrad® sealsure chemical indicator tape functioned as intended.The customer was unaware that the color change was correct.The technical support representative provided customer education by sending the customer the sterrad chemical indicator post-processing color document.The concomitant unit was serviced by a fse however, it is inconclusive if the maintenance performed on the unit was related to the reported issue.Review of the c of c was performed and found no anomalies that would contribute to the issue and lot history review found trending was not exceeded in this lot.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: 6207751
• MDR Text Key: 63371222
• Report Number: 2084725-2016-00792
• 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: 12/01/2016

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: 05/15/2018
• Device Catalogue Number: 14324
• Device Lot Number: 19716
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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