Model Number 39303 |
Device Problem
Component Misassembled (4004)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/13/2022 |
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 informed that two of the male external catheters in their order were defective and stuck together.The patient was not able to use them at all.The adhesive was stuck together as the drainage hole was too small.Because the urine started backing up into the catheter and on the patient.
|
|
Manufacturer Narrative
|
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.Correction: g 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.H3 other text : the device was not returned.
|
|
Event Description
|
It was reported that the patient informed that two of the male external catheters in their order were defective and stuck together.The patient was not able to use them at all.The adhesive was stuck together as the drainage hole was too small because the urine started backing up into the catheter and on the patient.
|
|
Search Alerts/Recalls
|