Catalog Number 309657 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/16/2022 |
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 plunger in the bd luer-lok¿ tip disposable syringe was loose and caused leakage during use.The following information was provided by the initial reporter: "certain syringes within cases wit lot: 2215953 and 2301840 have been found to have loose plungers.When the syringe is filled with liquid and the needle is changed, the syringe is losing volume with no movement on the plunger.This is also being found where there is any slight movement on the plunger once liquid is drawn into the syringe (approximately 2+ ml).".
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 30-jan-2023.H6: investigation summary: five samples from batch 2215953 were provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.Each sample was tested for leakage past stopper and leakage at luer connection.All samples from batch 2215953 were passed both functional testing.A device history record review was completed for provided batch numbers 2215953.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
|
|
Event Description
|
It was reported that the plunger in the bd luer-lok¿ tip disposable syringe was loose and caused leakage during use.The following information was provided by the initial reporter: "certain syringes within cases wit lot 2215953 and 2301840 have been found to have loose plungers.When the syringe is filled with liquid and the needle is changed, the syringe is losing volume with no movement on the plunger.This is also being found where there is any slight movement on the plunger once liquid is drawn into the syringe (approximately 2+ ml).".
|
|
Search Alerts/Recalls
|