MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CIDEX OPA SOLUTION; BIOCIDES SOLUTIONS (MED)

Catalog Number 20390

Device Problems Ambient Temperature Problem (2878); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Corrected catalog number is 20390_93.

Event Description

A customer reported using cidex® opa solution without measuring the temperature of the solution prior to use.There were no injuries or infections reported.The customer was advised that per the instructions for use (ifu), the solution must be at 68 degrees f for high level disinfection.The customer stated they have never measured the temperature prior to use.As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer does not follow the ifu when processing their scopes in cidex® opa solution since asp is not able to guarantee it has been high level disinfected.

Manufacturer Narrative

Corrected patient identifier from na to unk.Corrected age at time of event from na to unk.Corrected weight from na to unk.Corrected patient code from (b)(4).Asp investigation summary: the investigation included a review of the device batch record, supplier product evaluation, lot trending for the product malfunction code, and system risk analysis (sra).Device history record was reviewed and confirmed all the required process checks are complete and acceptable.There were no anomalies identified with the processing of this batch that would have affected the functional specifications of the product.The supplier was not notified of the reported issue is it was not identified to be a manufacturing or functional issue therefore retain samples were not tested.Lot history was reviewed for the reported lot and issue from 06/11/2016 to 12/08/2016; trending has not been exceeded.No visual analysis was performed.The customer did not return complaint samples or provide any photographic evidence for analysis.The sra indicates the risk associated to a hazardous situation of ¿exposure to biohazardous, pathogenic, or infectious material,¿ due to a manual disinfection issue is considered ¿low¿ risk.The assignable cause for the reported issue is failure to follow instructions.The customer was educated on the use of cidex opa by an asp senior clinician.The instructions for use (ifu) were reviewed by phone with the customer and training material was also mailed to the customer.This issue will continue to be tracked and trended.No further action is required.

• Brand Name: CIDEX OPA SOLUTION
• Type of Device: BIOCIDES SOLUTIONS (MED)
• 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: 6214366
• MDR Text Key: 63615682
• Report Number: 2084725-2016-00800
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991487
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Catalogue Number: 20390
• Device Lot Number: 618900105
• Other Device ID Number: 20390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• 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: Reuse
• Patient Sequence Number: 1