Catalog Number 367364 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 06/22/2018 |
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 tubing of the bd vacutainer® ultratouch¿ push button blood collection set was damaged and caused blood leakage.There was no report of exposure, injury, or medical intervention noted.
|
|
Manufacturer Narrative
|
Bd received a used sample from the customer facility for investigation.The sample was evaluated and the customer's indicated failure mode for a cut in the tubing of the incident lot was observed.However, bd was unable to determine the specific lot number associated with this complaint as the product packaging/labelling was not received.Therefore, a review of the device history record could not be conducted.Based on evaluation of the customer samples, the customer¿s indicated failure mode for a cut in the tubing of the incident lot was observed.Based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.As a result, bd is reviewing specific areas in the manufacturing process where the cause of this issue may have originated.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
|
|
Event Description
|
It was reported that the tubing of the bd vacutainer ultratouch push button blood collection set was damaged and caused blood leakage.There was no report of exposure, injury, or medical intervention noted.
|
|
Manufacturer Narrative
|
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no, device returned to manufacturer: yes.
|
|
Event Description
|
It was reported that the tubing of the bd vacutainer® ultratouch¿ push button blood collection set was damaged and caused blood leakage.There was no report of exposure, injury, or medical intervention noted.
|
|
Search Alerts/Recalls
|