Catalog Number 383516 |
Device Problem
Infusion or Flow Problem (2964)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It has been reported that one bd nexiva single port 20ga 1.00in (1.1 mm x 25 mm) has been found with tubing expanding during use.The following has been provided by the initial reporter: material no: 383516, batch no: unknown.It was reported that during a ct scar the iv tubing became swollen/engorged as if it was going to burst.No kinks were noted in the catheter after it was removed to be assessed.Event description per attached email states, it was reported that during the ct scan of a patient ( chest abdomen and pelvis) the iv tubing became swollen/engorged as if it was going to burst.The test was stopped and the iv was assessed, there were no kinks noted in the catheter.The iv was discontinued and a new catheter was placed.
|
|
Event Description
|
It has been reported that one bd nexiva single port 20ga 1.00in (1.1 mm x 25 mm) has been found with tubing expanding during use.The following has been provided by the initial reporter: material no: 383516, batch no: unknown.It was reported that during a ct scar the iv tubing became swollen/engorged as if it was going to burst.No kinks were noted in the catheter after it was removed to be assessed.Event description per attached email states, it was reported that during the ct scan of a patient ( chest abdomen and pelvis) the iv tubing became swollen/engorged as if it was going to burst.The test was stopped and the iv was assessed, there were no kinks noted in the catheter.The iv was discontinued and a new catheter was placed.
|
|
Manufacturer Narrative
|
H.6.Investigation: our quality engineer inspected the photographs and sample provided.Bd received one used nexiva 20ga unit without any packaging.One photo which was submitted for review.The photo displayed a nexiva 20ga unit with an attached needless connector.Through the visual inspection of the unit revealed the unit to be ballooned in 2 areas.The photographs revealed similarities to that of the returned unit.The reported issue was confirmed.Although the reported issue was confirmed, there was not enough evidence to be able to determine a root cause.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.
|
|
Search Alerts/Recalls
|