Model Number 367338 |
Device Problem
Volume Accuracy Problem (1675)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/27/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set.Medical device type: fpa.Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd vacutainer® push button blood collection set there was insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: "blood stopped flowing into tube for cat 367338 lot 1169911.The phlebotomist stated this was caused due to access issue to the vein.Per document, no patient adverse event to report.".
|
|
Manufacturer Narrative
|
H.6.Investigation summary: bd did not receive samples or photos from the customer in support of this complaint, therefore, 30 retention samples from the bd inventory were subjected to functional testing and the issue of insufficient blood was not observed.Therefore, this complaint cannot be confirmed based on retain sample testing results.As no customer samples or photos were received the scope of this investigation is limited.Bd is unable to confirm the customer reported failure mode of insufficient blood flow based on the retain sample testing analysis.Bd was unable to determine a root cause for the reported issue.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
|
|
Event Description
|
It was reported when using the bd vacutainer® push button blood collection set there was insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: "blood stopped flowing into tube for cat 367338 lot 1169911.The phlebotomist stated this was caused due to access issue to the vein.Per document, no patient adverse event to report.".
|
|
Search Alerts/Recalls
|