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 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® sealsure chemical indicator tape.Catalog number - the correct catalog number is 14202.Lot number - the correct lot number is 20315.

Event Description

A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s 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.The 1-114gbys and 1-114gdxi are related complaints from the same facility.This is one of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report numbers: 2084725-2017-00256 and 2084725-2017-00257.

Manufacturer Narrative

Correction lot # 20315 reported in error.Correct lot # is unk.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), product return evaluation, retains analysis and concomitant product evaluation.¿ the dhr review, trending analysis by lot number and retains analysis could not be performed as the lot number was not available.¿ product return/visual analysis was not performed since product was not returned for evaluation.¿ the sra indicates the risk associated with a quality problem with no impact on safety is "low." ¿ concomitant product evaluation determined a field service engineer (fse) visited the customer site to assess the sterrad® 100s unit.The fse ran a successful test cycle and confirmed that the unit met specification.There was insufficient information to determine the cause or resolution of the color-chemical indicator issue.The customer was unresponsive to multiple attempts at obtaining additional information.Should additional information become available, the complaint file will be re-opened and 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: 6593223
• MDR Text Key: 76180512
• Report Number: 2084725-2017-00257
• 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: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• 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
• Date Manufacturer Received: 06/21/2017
• 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