Catalog Number 301073 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/30/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).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 bd luer-lok¿ syringes had issues with "lack of sterility of 2 syringes (foreign matter)".
|
|
Manufacturer Narrative
|
Investigation: all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8154722 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.No defects confirmed based on the two photos received.Root cause not defined since samples were not received and the photos sent do not confirmed the defect communicated by customer.
|
|
Event Description
|
It was reported that the bd luer-lok¿ syringes had issues with "lack of sterility of 2 syringes (foreign matter)".
|
|
Search Alerts/Recalls
|