Model Number 385100 |
Device Problem
Defective Component (2292)
|
Patient Problem
Low Blood Pressure/ Hypotension (1914)
|
Event Date 03/28/2022 |
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 bd q-syte luer access split septum was damaged, but still operable and leaked.The following information was provided by the initial reporter: "immediately checked the pipeline and found that the blood pressure was not maintained.There is leakage of liquid at the needleless closed infusion joint of the diaphragm, which causes the booster medicine to fail to enter the body.Immediately disconnect the joint and adjust again if the liquid still leaks.".
|
|
Event Description
|
It was reported that bd q-syte luer access split septum was damaged, but still operable and leaked.The following information was provided by the initial reporter: "immediately checked the pipeline and found that the blood pressure was not maintained.There is leakage of liquid at the needleless closed infusion joint of the diaphragm, which causes the booster medicine to fail to enter the body.Immediately disconnect the joint and adjust again if the liquid still leaks.".
|
|
Manufacturer Narrative
|
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.
|
|
Search Alerts/Recalls
|