Catalog Number 383313 |
Device Problem
Material Frayed (1262)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/10/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that saf-t-intima w/y adapter yel 24ga x.75i catheter was frayed.The following information was provided by the initial reporter: it was reported that the catheter was frayed. verbatim: we have had several frayed 24 ga catheters and one frayed 22 ga catheter.
|
|
Manufacturer Narrative
|
H6: investigation summary bd received 1 sample submitted for evaluation.The reported issue was not confirmed upon inspection of the sample.Additional silicone from our manufacturing process was observed on the sample and could have been mistaken for product damage by the customer.The silicone is from our lubrication process that occurs at the final stages of production to assist in catheter insertion during application.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
|
|
Event Description
|
It was reported that saf-t-intima w/y adapter yel 24ga x.75i catheter was frayed.The following information was provided by the initial reporter: it was reported that the catheter was frayed. verbatim: we have had several frayed 24 ga catheters and one frayed 22 ga catheter.
|
|
Search Alerts/Recalls
|