Catalog Number 381212 |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/21/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that the bd insyte¿ iv catheter needle was loose.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "the cannula was not fit with the needle(very loose that effected to the cannula usually fall off.".
|
|
Event Description
|
It was reported that the bd insyte¿ iv catheter needle was loose.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "the cannula was not fit with the needle(very loose that effected to the cannula usually fall off.".
|
|
Manufacturer Narrative
|
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
|
|
Search Alerts/Recalls
|