Model Number 36303 |
Device Problem
Nonstandard Device (1420)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/19/2022 |
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 2 or 3 male external catheters had fallen off because of not enough adhesive and sometimes they did not roll down right and would stick to itself and knot up if some have too much glue and sometimes the patient had leak if there was not enough adhesive on them.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "mechanical failure".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.The device was not returned.
|
|
Event Description
|
It was reported that the 2 or 3 male external catheters had fallen off because of not enough adhesive and sometimes they did not roll down right and would stick to itself and knot up if some have too much glue and sometimes the patient had leak if there was not enough adhesive on them.
|
|
Search Alerts/Recalls
|