MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CYCLESURE® 24 BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL

Catalog Number 14324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Reference asp complaint # (b)(4).

Event Description

A customer reported a positive result with a cyclesure¿ 24 biological indicator (bi) after a cancelled sterrad¿ 100nx cycle.It is unclear whether or not the affected load was released for use on patients without reprocessing.Asp will continue to followup with the customer for additional information.There was 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 positive cyclesure¿ 24 biological indicators wherein the affected loads have been released for use without reprocessing.

Manufacturer Narrative

Lot # correction from unk to 18117242.The investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis, retains analysis and concomitant product evaluation.The dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.Trending analysis by lot number was reviewed from 06/30/2017 to 11/13/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the single cyclesure 24 bi was not returned for visual inspection.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.An issue with the concomitant sterrad 100nx sterilizer is unlikely as the customer stated the subsequent biological was negative.In addition, the fse stated the customer ran an empty cycle with a new bi of the same lot and the result was negative.The assignable cause could not be determined.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification, dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot.The customer stated subsequent bi was negative for growth.User error could not be confirmed.There were multiple attempts to obtain additional information but were unsuccessful.The issue will continue to be tracked and trended.

• Brand Name: CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine 92618 ; 9497893837
• MDR Report Key: 7089316
• MDR Text Key: 94893689
• Report Number: 2084725-2017-00670
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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: 05/31/2018
• Device Catalogue Number: 14324
• Device Lot Number: 18117242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/07/2018
• Date Device Manufactured: 06/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1