Model Number FOL0102 |
Device Problem
Disconnection (1171)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/22/2023 |
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 patient had 3 incidents over recent weeks when the plastic clip had become disconnected from the adhesive dressing.The patients were men and they had been confused so they might had been pulling at the statlock.Also stated that the catheter was no longer secured to the patient's leg.As per follow-up information received on 01mar2023, stated that the patients were confused and therefore it was possible they had been pulling on the catheters.
|
|
Manufacturer Narrative
|
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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 patient had 3 incidents over recent weeks when the plastic clip had become disconnected from the adhesive dressing.The patients were men and they had been confused so they might had been pulling at the statlock.Also stated that the catheter was no longer secured to the patient's leg.As per follow-up information received on 01mar2023, stated that the patients were confused and therefore it was possible they had been pulling on the catheters.
|
|
Search Alerts/Recalls
|