Device Problem
Increase in Suction (1604)
|
Patient Problem
Pain (1994)
|
Event Date 02/12/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
|
|
Event Description
|
It was reported that the patient last replaced the kit the purewick urine collection system got very high suction which was painful.No medical intervention was reported.
|
|
Event Description
|
It was reported that the patient last replaced the kit, the purewick urine collection system got very high suction which was painful.No medical intervention was reported.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿inadequate component (pump) selection inadequate system design/ inadequate component (pump and relief valve) selection ¿.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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
|