|
Model Number FOL0102 |
Device Problem
Incorrect Measurement (1383)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/02/2021 |
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 stat lock was too small and did not hold or stay locked.Customer took the patient to the emergency room twice because the catheter got pulled out.Customer stated that it happened twice already.Per follow up on 11jun2021, customer stated that the catheter was too small, hence it kept coming out.Nurses stated that the catheter was changed, and everything was okay now.Also reported that patient was not using stat lock because experienced allergic to it and would get blisters.No medical intervention was reported.
|
|
Event Description
|
It was reported that statlock was too small and did not hold or stay locked.Customer took the patient to the emergency room twice because the catheter got pulled out.Customer stated that it happened twice already.Per follow up on 11jun2021, customer stated that the catheter was too small, hence it kept coming out.Nurses stated that the catheter was changed and everything was okay now.Also reported that patient was not using statlock because experienced allergic to it and would get blisters.No medical intervention was reported.
|
|
Manufacturer Narrative
|
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure mode could be due to user issue, operator error, mechanical failure (eg: speed controller faulty).The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (latex foley catheter) product ifus were found to be adequate based on past reviews.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.The device was not returned.
|
|
Search Alerts/Recalls
|
|
|