|
It was reported that the resource nurse recently saw two patients with red painful perineum by using the purewick.Per notification received on 04nov2020, stated that the increase in suction was the cause for red perineum and would not know what was the recommended maximum suction level would be.Also stated that the red tender area was the vaginal area where the end of the wick would be positioned.Informed the nurse that the minimum suction for the purewick is 40 mmhg and would not have the max recommendation.The suction was in the wick and did not suction against the patient tissue.Per follow up via phone on 09nov2020, the customer noted that the suction on the device was set high by the staff and sometimes was set to the maximum suction (260mmhg) which the nurse believed that this was caused the redness on the patients.The customer added that since the call with mis, and instructed the staff not to exceed 80mmhg suction which seems to be helping.
|
|
It was reported that the resource nurse recently saw two patients with red painful perineum by using the purewick.Per notification received on 04nov2020, stated that the increase in suction was the cause for red perineum and would not know what was the recommended maximum suction level would be.Also stated that the red tender area was the vaginal area where the end of the wick would be positioned.Informed the nurse that the minimum suction for the purewick is 40 mmhg and would not have the max recommendation.The suction was in the wick and did not suction against the patient tissue.Per follow up via phone on 09nov2020, the customer noted that the suction on the device was set high by the staff and sometimes was set to the maximum suction (260mmhg) which the nurse believed that this was caused the redness on the patients.The customer added that since the call with mis, and instructed the staff not to exceed 80mmhg suction which seems to be helping.
|
|
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to occurred with the hospital wall suction and not the purewick itself and technically be a result of the wall suction unit which is not our device.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "contraindications: -patients with urinary retention warnings: -never insert the purewick female external catheter into vagina, anal canal or other body cavities.For external use only.-do not use purewick female external catheter with bedpan or any material that does not allow for sufficient airflow.-to avoid potential skin injury, never push or pull the purewick female external catheter against the skin during placement or removal.-discontinue use if an allergic reaction occurs.-reuse and/or repackaging may create a risk of patient or use infection, compromise the structural integrity and/or essential material and design characteristics of the device which may lead to device failure, and/or lead to injury or illness of the patient.-after use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Precautions: -not recommended for patients who are: -agitated, combative or unconperative and might removw the purewick female external catheter.-having frequent episodes of bowel incontinence without a fecal management system in place.-experiencing skin irritation or breakdown at the site -experiencing moderate/heavy menstruation and cannot use a tampon.-do not use barrier cream on the perineum when using the purewick female external catheter.Barrier cream may impede suction -not recommended for use on patients who have undergone recent surgery of the external urogenital tract.-always assess skin for compromise nd perform perineal care prior to placement of a new purewick female external catheter.-maintain suction until the purewick female external catheter is fully removed from he patient to avoid urine backflow.Recommendations: -perform each step with clean technique.N the home setting, wash hands thoroughly before device placement.-prior to connecting the purewick female external catheter to hospital wall suction tubing, verify suction function by covering the open end of the suction tubing with one hand and observing the pressure dial.If the pressure does not increase when the line is covered, verify that the tubing is secured, connected and not kinked.-ensure the purewick female external catheter remains in the correct position after turning the patient.Remove the purewick female external catheter prior to ambulation.-properly placing the purewick female external catheter snugly between the labia and gluteus holds the purewick female external catheter in place for most patients.Mesh underwear may be useful for securing the purewick female external catheter for some patients.-assess device placement and patient's skin at least every 2 hours.-replace the purewick female external catheter every 8-12 hours or when soiled with feces or blood.-if using wall suction, change suction tubing per hospital protocol or at least every thirty (30) days.-if using purewick urine collection system, replace accessories per purewick urine collection system user guide." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
|
