Model Number 305488 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/10/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that 2 bd one-piece sharps collector lid was broken.The following information was provided by the initial reporter: this is a report about broken lids of sharps collector.The customer reported that lids did not close, were detached, and had bent marks.
|
|
Manufacturer Narrative
|
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.D.4 device expiration date: na.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
H6: investigation summary 1 sample and photos were returned by the customer.According to the customer's report, the lid does not shut was verified.The investigation performed on basis of photo and sample representation.Requirement(s): the lids should be properly installed while bottles are molded (hot) so that the lids snap onto the containers and remain snapped in place permanently.Investigation: proper installation of the caps require the bottles & caps to be warm (right after molding) and require significant force to secure the cap completely to the bottle.This was being done manually throughout 2022 and prior.Due to the high physical requirements needed, some operators may not have had the strength necessary to complete this task efficiently.This was recognized and an automatic cap press was built in late 2022 to alleviate the issue.
|
|
Event Description
|
It was reported that 2 bd one-piece sharps collector lid was broken.The following information was provided by the initial reporter: this is a report about broken lids of sharps collector.The customer reported that lids did not close, were detached, and had bent marks.
|
|
Search Alerts/Recalls
|