Model Number 119108 |
Device Problems
Partial Blockage (1065); Inaccurate Flow Rate (1249)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/06/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
|
|
Event Description
|
It was reported that the urine did not flow, after inserting the temperature sensing catheter into the patient.The use was discontinued because there was no urine flow even after insertion.
|
|
Manufacturer Narrative
|
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.A potential root cause for this failure mode could be "tooling misalignment.Tooling wear.Silicone inside the lumen.Incorrect use of tool".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.The actual/suspected device was evaluated.
|
|
Event Description
|
It was reported that the urine did not flow, after inserting the temperature sensing catheter into the patient.The use was discontinued because there was no urine flow even after insertion.
|
|
Search Alerts/Recalls
|