| Catalog Number 20391 |
| Device Problem
Use of Device Problem (1670)
|
| Patient Problems
Dyspnea (1816); Headache (1880); Nasal Obstruction (2466); Decreased Sensitivity (2683); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)
|
| Event Date 12/27/2022 |
|
Event Type
Injury
|
|
Event Description
|
|
It was initially reported on (b)(6) 2023, a female health care worker (hcw) experienced ¿skin rash and respiratory problems, both mild,¿ noted possibly due to repeated exposure to cidex opa solution.The hcw first experienced the symptoms in (b)(6) 2022, and reported experiencing the symptoms for about 8 months ¿with intensity variations.¿ the reported recommended treatment included, ¿hydrocortisone cream, hydrating cream, and decongestants,¿ noted to be over-the-counter (otc) medications.It was further provided that reprocessing was done manually in a tray that frequently had no lid.The room was reported to be small with low ventilation.Other chemicals were used in the same room, including enzymatic detergents not manufactured by asp.The frequency of exposure to the product was 8 hours each workday, and the personal protective equipment (ppe) worn included short gloves to wrist only, short-sleeved gown which was not fluid-repellent, and common face mask.Additional event information reported that on (b)(6) 2023, the last day the hcw worked with cidex opa, she left work at approximately 4:00 pm and went home.It was reported she ¿felt very bad¿ and laid down.When she woke up 6 hours later at 10 pm, she noted ¿severe allergic-type¿ rash on her left forearm only.The hcw suggested it happened due to direct contact with tray containing cidex opa.The hcw reported the tray was made of dark plastic, and the container was ¿for home use (tupperware type)¿.She also suggested cidex opa may have splashed on her arm, although she confirmed there was no skin discoloration.Additional event clarification and clinical details were received on 23-oct-2023, which provided the timeline for the alleged event as follows: the hcw started working with cidex opa approximately(b)(6) 2022 as an endoscopy assistant.She was directly involved in all reprocessing steps, including pre-cleaning scopes with enzymatic detergent after patient use, and cleaning with surgizime l5 enzymatic detergent (not manufactured by asp) prior to high-level disinfection with cidex opa.She reported her first symptoms were mild, and later worsened.Symptoms included dry nose, throat, and mouth, and headache.She reported she did not have any record of other respiratory illness or infections at that time.She was seen by a doctor and treated with amoxicillin (antibiotics) for one week.She was instructed to take ibuprofen, and continue the following months whenever headache was severe.The additional information further reported that in (b)(6) 2023, the hcw went to the emergency room (er) for symptoms of difficulty breathing/swallowing.She does not remember what precise diagnosis was given at that time; however, she was treated with methylprednisolone (intravenous corticosteroid), cetirizine (oral), two nasal sprays - hexaler (corticosteroid) and hypersol (sodium chloride/hypertonic solution).The hcw was also recommended to swish with chamomile tea.The hcw additionally presented in the er with an earache and received otosporin dexa ear drops (antibiotic/steroid).She reported she did not have any other respiratory illness or infections, except for the previously reported symptoms of dry nose, throat, mouth, and headache.The hcw additionally experienced loss of taste in (b)(6) 2023.She noted at first it was mild but increased over time.She denied other respiratory illness/infections, and reported she did not have covid-19 (as far as she was aware of), but she has not had any tests done recently either.The hcw clarified she only had skin discomfort prior to the rash that occurred on (b)(6) 2023, and she did not see a doctor for the symptoms prior to that day.The hcw additionally reported experiencing other symptoms on (b)(6) 2023, including congestion/runny nose, headache, stinging in nose/throat, and general discomfort; however, no treatment was received on (b)(6) 2023.After this event, she saw a dermatologist who recommended dermexane clobetazol (hydrocortisone cream), cetaphil (hydrating cream), and decongestants.She also reported she received deltisone (oral corticosteroid), however she discontinued this medication after 2 days due to diarrhea.Potential diagnosis was given by dermatologist as ¿allergy due to contact with opa¿, however no definitive allergy skin testing was done for cidex opa.The hcw was seen by an occupational clinician and returned to work on (b)(6) 2023; however, she performed administrative tasks in another area until (b)(6) 2023.It was reported the hcw went on medical leave on (b)(6) 2023, ¿to stop exposure to the work environment.¿ the hcw was seen by a doctor for the rash, and the translated clinic note stated, ¿i certify that the patient was assessed due to skin rash on her forearm and possible intoxication.I indicate her to rest up to (b)(6) 2023.¿ the hcw was seen by a dermatologist on (b)(6) 2023, who noted she ¿experienced acute allergic dermatitis due to opa products, is recovering well of her left forearm.She is considered recovered dermatologically speaking.Use of cetaphil hydrating cream is recommended as well as sunscreen.She is suggested to visit the otorhinolaryngologist since she has respiratory symptoms, potentially related to the inhalation of opa fumes.¿ and the hcw was seen by allergologist on (b)(6) 2023, who noted ¿patient with history of irritant contact dermatitis possibly related to orthophthalaldehyde 0.55% used in her job.¿ referral to another dermatologist was made for contact testing.Allergologist also noted ¿until no diagnosis from certainty is obtained, it is suggested not to return to her job¿s activities.¿ on 23-oct-2023, the hcw reported she was still on medical leave and has not been exposed to cidex opa, however, she continued to have respiratory symptoms.Based on new information received on 23-oct-2023, this event is now deemed reportable out of an abundance of caution as a serious injury.It was initially reported the hcw experienced rash and unknown respiratory reaction potentially related to exposure of cidex opa, and treatment/medication reported at that time was otc.New information reported hcw experienced additional symptoms, including neurological and respiratory symptoms such as difficulty breathing, which required medical treatment.It is not confirmed that symptoms were potentially related to exposure of cidex opa or possibly related to other chemicals used.Allergy skin testing was recommended; however, diagnostic testing has not been completed and there are no results.In addition, it is not known if hcw potentially had symptoms related to other respiratory infections, such as covid-19, as testing was not done.Lastly, there were no product problems reported with cidex opa, but use error was identified and it was reported solution was used in a small, low ventilated room in trays with no lids.
|
| |
|
Manufacturer Narrative
|
|
E1.Initial reporter phone number: (b)(6).Per the cidex opa instructions for use (ifu) under precautions: when disinfecting devices, use gloves of appropriate type and length.Nitrile rubber gloves or butyl rubber gloves may be used.When using latex rubber gloves, the user should double glove and/or change single gloves frequently, e.G., after 10 minutes of exposure.For those individuals who are sensitive to latex or other components in latex gloves, 100% synthetic copolymer gloves are recommended.Note: contact with cidex opa solution may stain exposed skin or clothing.Eye protection, such as goggles or face shields, should always be used when handling cidex opa.Fluid repellent gown or apron should always be used to prevent opa from getting on clothing or skin.Use cidex opa solution in a dedicated room with adequate ventilation and in closed containers with tight-fitting lids.Please reference local/state/country requirements for appropriate number of air exchanges per hour.If adequate ventilation is not provided by the existing air handling system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air.Cidex opa ifu under warnings: may elicit an allergic reaction.Possible allergic reactions, including anaphylaxis have been reported in rare instances.In the majority of these instances health care workers were not using the product in a well-ventilated room or not wearing proper personal protective equipment.(see precautions).Avoid contact with eyes, skin, or clothing.(see precautions ¿ for important information on how to protect eyes, skin and clothing.) direct contact with eyes may cause irritation.Direct contact with skin may cause temporary staining.Repeated contact may cause skin and respiratory sensitization.Sensitization can result in anaphylaxis in rare instances.In case of eye contact, immediately flush eyes with large quantities of water for at least 15 minutes.Seek medical attention.In case of skin contact, immediately wash with soap and water.Refer to the sds for additional information.Do not form sprays, mists or aerosols of this product.Avoid exposure to ortho-phthalaldehyde vapors, as they may be irritating to the respiratory tract and eyes.May cause stinging sensation in the nose and throat, discharge, coughing, chest discomfort and tightness, difficulty with breathing, wheezing, tightening of throat, urticaria (hives), and/or sensitization/anaphylaxis in rare instances, rash, loss of smell, tingling of mouth or lips, dry mouth or headache.May aggravate a pre-existing asthma or bronchitis condition.In case of adverse reactions from inhalation of vapor, move to fresh air.If breathing is difficult, oxygen may be given by qualified personnel.If symptoms persist, seek medical attention.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
|
| |
|
Manufacturer Narrative
|
|
Asp investigation summary: ¿ the batch history record could not be reviewed due to unknown lot number.¿ trending analysis could not be conducted due to unknown lot number.¿ review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the involved cidex opa solution was not returned for further analysis, and no product evaluation or supplier investigation could be performed due to unknown lot number.The most likely assignable cause for this event may be attributed to use error.The customer was retrained on the appropriate procedure as per the cidex opa instructions for use.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).
|
| |
|
Search Alerts/Recalls
|
|
