Model Number PW100 |
Device Problem
Increase in Suction (1604)
|
Patient Problem
Skin Tears (2516)
|
Event Date 09/03/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that the patient had been experiencing issues with suction on purewick urine collection system.Patient described purewick female external catheter being full of urine when they woke up but as soon as they turned machine off, urine spilled everywhere.Patient also said one morning the machine suctioned their skin so hard when they woke up that it left a tear on their skin.Representative could tell from the description that they had not been doing the pinch test so there had been no airflow for the vacuum to suction properly.Also advised the pinch test and explained how to do it.Patient had been using the purewick product for less than 90 days.
|
|
Event Description
|
It was reported that the patient had been experiencing issues with suction on purewick urine collection system.Patient described purewick female external catheter being full of urine when they woke up but as soon as they turned machine off, urine spilled everywhere.Patient also said one morning the machine suctioned their skin so hard when they woke up that it left a tear on their skin.Representative could tell from the description that they had not been doing the pinch test so there had been no airflow for the vacuum to suction properly.Also advised the pinch test and explained how to do it.Patient had been using the purewick product for less than 90 days.
|
|
Manufacturer Narrative
|
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "inadequate component (pump and relief valve) selection".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "operating suction range: approximately 120 mmhg ¿ 140 mmhg (2.3 ¿ 2.7 psi) maximum suction level: 182 mmhg (3.5 psi).Discontinue use if an allergic reaction occurs.Not recommended for users who are experiencing skin irritation or skin breakdown in device contact areas." 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.
|
|
Search Alerts/Recalls
|