BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 32G 4MM PRO 100 BOX 1200 CA; NEEDLE, HYPODERMIC, SINGLE LUMEN
|
Back to Search Results |
|
Model Number 320555 |
Device Problem
Improper Flow or Infusion (2954)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
H3 other text : device not available.
|
|
Event Description
|
Consumer reported needle clog during priming, stated that there is no insulin flow.Consumer does not re-use.Lot #: 3066037 catalog #: 320555 date of event: unknown samples: discarded.
|
|
Manufacturer Narrative
|
Additional information added to h6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
|
|
Search Alerts/Recalls
|
|
|