Model Number 1758SI16 |
Device Problems
Inaccurate Flow Rate (1249); Defective Component (2292)
|
Patient Problems
Pain (1994); Urinary Retention (2119)
|
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 catheters did not drain properly.The complainant reported that the patient complained of pain or ¿full feeling¿ and they saw that there wasn't any urine output.The complainant noted that the patient would then be repositioned or the staff would have the patient get up to walk and the bag fills with urine.The complainant reportedly talked to the staff about the vent on the bags and doing an accordion motion prior to inserting the foleys, but the staff reportedly mentioned that the bags are sealed so tight that the vent did not seem to work like it should.No medical intervention was reported.
|
|
Manufacturer Narrative
|
The device was not returned for evaluation.A potential failure mode could be ¿collapsed lumen.Blocked lumen¿.A potential root cause for this failure could be "biological deposits or physiological obstruction (¿ patient position ¿ kinked catheter)".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." 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.
|
|
Event Description
|
It was reported that the catheters did not drain properly.The complainant reported that the patient complained of pain or ¿full feeling¿ and they saw that there wasn't any urine output.The complainant noted that the patient would then be repositioned or the staff would have the patient get up to walk and the bag fills with urine.The complainant reportedly talked to the staff about the vent on the bags and doing an accordion motion prior to inserting the foleys, but the staff reportedly mentioned that the bags were sealed so tight that the vent did not seem to work like it should.No medical intervention was reported.
|
|
Search Alerts/Recalls
|