Catalog Number 383512 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/10/2020 |
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.(b)(4).
|
|
Event Description
|
It was reported that 3 bd nexiva¿ closed iv catheter systems experienced no label or missing label information.The following information was provided by the initial reporter: the customer reported about improper printing on the package.
|
|
Event Description
|
It was reported that 3 bd nexiva¿ closed iv catheter systems experienced no label or missing label information.The following information was provided by the initial reporter: the customer reported about improper printing on the package.
|
|
Manufacturer Narrative
|
H6: investigation summary: bd received two photographs which displayed missing print on the unit label.Your reported issue was confirmed as the photographs observed displayed that the packages contained missing print on the unit label.Based on the observations made during the investigation, there are two contributing factors that may have occurred during the manufacturing process.The missing print is likely due to the top web splice when a new roll of top web is connected to the end of the current roll.This could result in an operator error as the operator is to sort through the rejected parts and hand pack the dispenser with the approved parts.The other situation that may take place in the manufacturing process can occur due to a clogged/damaged print head, printer failure or software issue.Parts with missing print from these potential causes can be automatically packaged into dispenser boxes.A clogged or damaged printhead is unlikely to result in completely blank units: some text would likely be printed.A software issue or a printer failure is likely to result in completely blank top web label.A corrective action project #scm-333 has been initiated to implement a vision inspection system that will inspect top web label for missing print.A device history record review showed no non-conformances associated with this issue during the production of this batch.
|
|
Search Alerts/Recalls
|