Catalog Number 393229 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
Patient Problem/Medical Problem (2688)
|
Event Date 12/12/2019 |
Event Type
Injury
|
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 has been reported that the bd venflon¿ pro safety peripheral safety iv catheter has been found defective during use.The following has been provided by the initial reporter: during removing the g16 vps intravenous cannula, the tip that remained in the vessel was torn off.The doctor on duty was informed.The end of the venflon was secured and the vascular surgeon was consulted.A local dressing was put on above the puncture site.The catheter remaining in the vessel was removed in the operating room conditions.
|
|
Manufacturer Narrative
|
H.6 investigation summary: one sample was received by our quality team for evaluation.The used sample was subjected to visual inspection and was confirmed that the sample is not a venflon pro safety (vps) sample.There is a different type of protection cap and cannula hub were observed from the returned used sample.As the returned used sample does not belong to bd tuas, no further investigation was done.Therefore, the root cause cannot be determined.A dhr was not performed as the sample provided was not a bd product.Complaint will be reopened if a correct sample is returned for investigation.
|
|
Event Description
|
It has been reported that the bd venflon¿ pro safety peripheral safety iv catheter has been found defective during use.The following has been provided by the initial reporter: during removing the g16 vps intravenous cannula, the tip that remained in the vessel was torn off.The doctor on duty was informed.The end of the venflon was secured and the vascular surgeon was consulted.A local dressing was put on above the puncture site.The catheter remaining in the vessel was removed in the operating room conditions.
|
|
Search Alerts/Recalls
|