Catalog Number 302830 |
Device Problem
Melted (1385)
|
Patient Problem
No Information (3190)
|
Event Date 12/20/2018 |
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 an unspecified number of the bd¿ syringe with bd luer-lok¿ tips were contained in packaging that appeared melted.
|
|
Event Description
|
It was reported that an unspecified number of the bd¿ syringe with bd luer-lok¿ tips were contained in packaging that appeared melted.
|
|
Manufacturer Narrative
|
Investigation: one photo was provided for evaluation.It shows four packaging top webs, they have areas where the top web got melted, therefore failure mode is verified.This occurred during a variation in the multivac packaging process.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
|
|
Search Alerts/Recalls
|