Catalog Number 381533 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problems
Pain (1994); Foreign Body In Patient (2687)
|
Event Date 08/09/2021 |
Event Type
Injury
|
Event Description
|
It was reported a bd insyte autoguard shielded iv catheter had the cannula break off inside the patient's vein, requiring surgical intervention.Additionally, another catheter broke off in the patient's vein, also requiring surgical intervention.The following information was provided by the initial reporter: ".I have been injured by you guys twice i have had two ivs break in my arm in a span of two months which both require surgery".
|
|
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 a bd insyte autoguard shielded iv catheter had the cannula break off inside the patient's vein, requiring surgical intervention.Additionally, another catheter broke off in the patient's vein, also requiring surgical intervention.The following information was provided by the initial reporter: ".I have been injured by you guys twice i have had two ivs break in my arm in a span of two months which both require surgery.".
|
|
Manufacturer Narrative
|
H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received eight photos.One of the photos displayed a view of the catheter adapter that appeared to be missing the catheter tubing.Damage to the catheter tubing that leads to separation from the catheter adapter can occur both in the manufacturing environment and in the user environment during application.Unfortunately, the photo provided a very limited view.In order to perform a comprehensive investigation for this defect, a physical sample of the adapter and/ or catheter tubing would be required so the separation site could be inspected microscopically.Based on the photos alone, bd was unable to determine a definite root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.
|
|
Search Alerts/Recalls
|