Catalog Number 1022-156-032 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/08/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that 6 of the bd female luer-lok adapter had foreign matter in fluid pathway.The following information was provided by the initial reporter, translated from spanish to english: the purpose of this email is to notify us that our production team reported 6 pieces with the female luer with dirt, the total order was processed, so we only need you to help us take corrective actions such as checking inventories, root cause.
|
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that 6 of the bd female luer-lok adapter had foreign matter in fluid pathway.The following information was provided by the initial reporter, translated from spanish to english: the purpose of this email is to notify us that our production team reported 6 pieces with the female luer with dirt like shown in the photo below, the total order was processed, so we only need you to help us take corrective actions such as checking inventories, root cause.
|
|
Manufacturer Narrative
|
H6: investigation summary a complaint of adaptors being received with dirt on them was reported by the customer.Photos were provided by the customer that show the product.Foreign matter could not be seen in the photo.A device history review was performed for part 1022-156-032.From the dhr review of lot no.2256443, there was no recorded activity associated with this condition.Additionally, there were 13 in-process inspections performed that totaled 832 total parts inspected with 0 defects noted for batch number 2256443.The complaint cannot be confirmed as the image provided does not display any foreign matter, and physical samples have not been provided.
|
|
Search Alerts/Recalls
|