Catalog Number 394901 |
Device Problem
Leak/Splash (1354)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/01/2020 |
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.(b)(4).
|
|
Event Description
|
It was reported that the connecta plus3 blue blend experienced leakage.The following information was provided by the initial reporter: during anesthetic (propofol) infusion, leakage occurred from the connection between this product and non-bd¿s extension tubing.
|
|
Manufacturer Narrative
|
H.6.Investigation: a device history record review was performed for provided lot number 9262741 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.The samples were visually inspected and functionally tested.All results were within specification with no signs of leakage observed.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.
|
|
Event Description
|
It was reported that the connecta plus3 blue blend experienced leakage.The following information was provided by the initial reporter: during anesthetic (propofol) infusion, leakage occurred from the connection between this product and non-bd¿s extension tubing.
|
|
Manufacturer Narrative
|
H.6.Investigation: complaint coding was updated with imdrf coding.A device history record review was performed for provided lot number 9262741 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.The samples were visually inspected and functionally tested.All results were within specification with no signs of leakage observed.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.
|
|
Event Description
|
It was reported that the connecta plus3 blue blend experienced leakage.The following information was provided by the initial reporter: during anesthetic (propofol) infusion, leakage occurred from the connection between this product and non-bd¿s extension tubing.
|
|
Search Alerts/Recalls
|