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

Catalog Number 20390

Device Problems Inadequate or Insufficient Training (1643); Environmental Compatibility Problem (2929)

Patient Problems Chemical Exposure (2570); No Code Available (3191)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No further information is known at this time.Advanced sterilization products (asp) will continue to follow-up for additional information.

Event Description

It was reported a healthcare worker (hcw) suffered a complete and permanent loss of smell after working with cidex opa solution for over 9 years.The hcw is employed as a sonographer and stated they perform up to six ultrasound studies each shift and are responsible for cleaning and disinfecting the instruments after each procedure.The hcw stated ppe was not worn while handling cidex opa solution and was never made aware of the precautions against the exposure to fumes and vapors from the product.They state the room in which they clean and disinfect was poorly ventilated.It is unknown what other chemicals were in the room, if any.The cidex opa solution instructions for use (ifu) clearly states when disinfecting devices, use gloves of appropriate type and length, eye protection and fluid-resistant gowns, use in a well-ventilated area and in closed containers with tight fitting lids.If adequate ventilation is not provided by the existing air conditioning system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthaldehyde from the air.Under the section of "user training" in the cidex opa solution ifu, it also states the user should be adequately trained in the decontamination and disinfection of semi-critical medical devices and the handling of liquid chemical germicides.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included a review of the batch history record, complaint trending, functional analysis and retains analysis.The batch history record could not be reviewed as the lot number was not available.Complaint trending could not be performed as the lot number was not available.The sra indicates the risk associated with exposure to toxic or corrosive material is "medium." visual analysis was not performed as the product was not available for return.The supplier was not notified of the issue as the issue was not identified as a manufacturing or functional issue.Retains testing was not performed as the lot number was not available.The likely cause of this issue is due to inadequate ventilation and inadequate use of personal protective equipment (ppe).The issue will continue to be tracked and trended.

• 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: 5898497
• MDR Text Key: 52833834
• Report Number: 2084725-2016-00490
• 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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20390
• Other Device ID Number: 20390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability