Model Number 309658 |
Device Problems
Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/02/2021 |
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 3ml bd plastipak¿ syringe luer-lok¿ tip experienced device damage while still considered operable.The following information was provided by the initial reporter: the nurses noted a defect in the rubber of the piston.Indeed, the latter seems to hang to the wall in an abnormal way.The plunger seems to stick to the wall in an abnormal way, thus causing a possible misreading of the volume taken.Current condition of the patient : no clinical consequences.
|
|
Manufacturer Narrative
|
H.6.Investigation: one photo was received and evaluated.The photo showed two loose empty 3ml syringes with their stoppers at approximately 1ml marking.Red arrows pointed to the left side of the stopper of one syringe in the photos.Slight stopper angularity was observed in that syringe.The angularity appeared to be well within product specification for 3ml syringes.Slight stopper angularity is considered a cosmetic defect not affecting function.The effects on volumetric accuracy would be well within the tolerances per iso and product specification.The reported defect was not confirmed in the photos received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.
|
|
Event Description
|
It was reported that the 3ml bd plastipak¿ syringe luer-lok¿ tip experienced device damage while still considered operable.The following information was provided by the initial reporter: the nurses noted a defect in the rubber of the piston.Indeed, the latter seems to hang to the wall in an abnormal way.The plunger seems to stick to the wall in an abnormal way, thus causing a possible misreading of the volume taken.Current condition of the patient : no clinical consequences.
|
|
Search Alerts/Recalls
|