Catalog Number 305822 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/21/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and / or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It has been reported that the cap tip syr ll / ls ster lf pp nat 50 / tray has been found experiencing four occurrences of containing foreign matter before use.The following has been provided by the initial reporter: the user complained that black foreign particles were found inside the packing and the syringe cap.
|
|
Manufacturer Narrative
|
Investigation: two photos and four convenience trays from batch 8149998 (p/n 305822) were received and evaluated.One of the trays was opened and three trays were fully sealed.It was observed five tip caps contained brown and black embedded foreign matter particles.The foreign matter appeared to be burnt plastic and four of the tip caps contained particles larger than level 3 in size which was rejectable per product specification.One tip cap contained a particle equal to level 2 in size and was acceptable per product specification.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Per procedure, after start up, all molded parts are scrapped until no degraded plastic is observed.If this is not performed thoroughly a piece with this condition can get through.This type of defect is cosmetic and does not pose risk to the customer.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
|
|
Event Description
|
It has been reported that the cap tip syr ll/ls ster lf pp nat 50/tray has been found experiencing four occurrences of containing foreign matter before use.The following has been provided by the initial reporter: the user complained that black foreign particles were found inside the packing and the syringe cap.
|
|
Search Alerts/Recalls
|